Medical device system and method for automated evaluation of the status of implantable medical devices

Abstract

A medical device system is provided comprising an implantable medical device (IMD) having a detection unit, a processing unit, and a telemetry unit, an external server, and a clinician device. The IMD detection unit is configured to detect multiple parameters, and the IMD processing unit is configured to identify that the IMD is implanted in a patient based on at least one of the multiple parameters. Furthermore, the processing unit is configured to transmit at least one of the multiple parameters to the external server via the telemetry unit. The external server is configured to process at least one of the multiple parameters and create a dataset associated with the IMD and / or the patient based on at least one of the multiple parameters. The dataset contains at least one piece of information for making decisions associated with the IMD and / or the patient. Furthermore, the external server is configured to initiate transmission of the dataset to the clinician device.

Description

【Technical Field】 【0001】 The present invention relates to a medical device system and method for automatically evaluating the state of an implantable medical device (IMD) immediately after implantation into a patient. After detecting the implanted state, the present invention includes an external server that processes at least one parameter detected by the IMD. The external server generates a data set based on the at least one parameter and transmits the data set to a clinician device. The present invention enables automatic analysis of the state of the IMD and the state of the patient after the implantation procedure and facilitates the workflow in the clinic. 【0002】 Background Art Implantable medical devices (IMDs) are used in various therapeutic applications to ensure reliable treatment of the symptoms of a patient's condition. Some IMDs have the ability to deliver therapies and sense device parameters and / or patient parameters using sensing components and / or sensing devices. 【0003】 In a typical clinical workflow, the IMD is implanted during a surgical procedure, and subsequently the patient stays in the hospital for observation. Before discharging the patient, a final check including the IMD device parameters and the patient parameters sensed by the IMD needs to be performed by a clinician. The check is performed, for example, by establishing a communication connection between the IMD and a programmer device via inductive coupling, whereby the parameters of interest are obtained by the programmer via the communication connection. Based on the parameters, the clinician decides on reprogramming the IMD and / or discharging the patient. The billing of the IMD follows an independent process initiated by a representative of the IMD manufacturer at the clinic or the clinic. 【0004】 This workflow involves several manual steps requiring a clinician's visit to the practice and the use of an IMD programming device. Furthermore, invoicing for IMD and related services is treated as a standalone process and requires additional manual steps. 【0005】 Therefore, known methods and systems need to be improved from the standpoint of automation and workflow efficiency. 【0006】 Summary of the Invention Various embodiments described herein may satisfy the above-mentioned needs at least in part. 【0007】 According to a first aspect of the present invention, a medical device system is provided comprising an implantable medical device (IMD) having a detection unit, a processing unit and a telemetry unit, an external server and a clinician device. 【0008】 The IMD detection unit is configured to detect multiple parameters, and the IMD processing unit is configured to identify that an IMD has been implanted in a patient based on at least one of the multiple parameters. Furthermore, the processing unit is configured to send at least one of the multiple parameters to an external server via a telemetry unit. The external server is configured to process at least one of the multiple parameters and create a dataset associated with the IMD and / or the patient based on at least one of the multiple parameters. The dataset contains at least one piece of information for making decisions associated with the IMD and / or the patient. Furthermore, the external server is configured to initiate transmission of the dataset to a clinician device. 【0009】 The proposed medical device system solves the described problem by providing an automated workflow for evaluating the state of the IMD after implantation. An IMD is a device configured to be inserted at least partially into the body of a human or animal, providing at least one diagnostic or therapeutic function therein. The IMD according to the present invention comprises a detection unit, a processing unit, and a telemetry unit. The detection unit may comprise any type of sensor, e.g., a sensor for electrical, mechanical, and / or chemical signals. The processing unit is configured to process the detected signals and derive and perform the resulting actions of the IMD. The telemetry unit is configured to wirelessly send and receive data to and from the IMD. First, the IMD itself detects or identifies its implanted state immediately after implantation. This is done, for example, by measuring several parameters by the detection unit and then evaluating the parameters by the processing unit. For example, at least one of the several parameters may indicate the implanted state of the IMD. In the next step, the processing unit initiates the telemetry unit to send at least one parameter to an external server. The external server may be any type of remote computing entity for storing, processing, allocating, and transferring data. At least one parameter is analyzed by an external server, for example, by comparison with a reference value or threshold and / or by analysis of the parameter in the context of further patient data. 【0010】 For example, analysis is performed using an artificial intelligence model, at least in part on training data. Generally, the AI ​​model may be supplied with a large amount of training data, particularly data from IMDs, and data from patients who are wearing or have recently had an IMD implanted. For example, training data may be collected from IMDs by querying using a programmer device, or via remote monitoring, particularly technical data or data about the functionality of the IMD associated with the patient. Training data from patients can be collected via sensors on the IMD (e.g., ECG data) or other sensors. 【0011】 The amount of training data useful for identifying IMD and / or patient status may change over time, depending on the analysis applied to ongoing data collection efforts across a pool of patients with such IMDs. Information collection may be supported by any one of several possible means, including but not limited to wearable devices, mobile devices, or bedside units that relay patient and device status data to a central storage facility. An artificial intelligence-based investigation of the aggregate of information collected from the patient pool may help improve the predictability and accuracy of post-implantation IMD status and / or patient status. 【0012】 Furthermore, an external server generates a dataset based on an analysis of at least one parameter. The dataset is understood as a set of data containing a suggestion for one subsequent action associated with the patient and / or IMD. The external server then begins transmitting the dataset to the clinician device. The clinician device is understood as any device that can at least inform the clinician of the dataset. For example, the dataset contains at least one piece of information for making decisions associated with the IMD and / or the patient. The clinician reviews the dataset on the clinician device and uses it as a basis for determining further steps related to the IMD and / or the patient. In exemplary embodiments, the clinician device provides access to the clinician through an authentication step. In further embodiments of the present invention, the clinician device provides means for querying the IMD and modifying at least one programming parameter of the IMD. According to one embodiment, the external server is connected to the clinic's electronic health record (EHR) system to synchronize data from the IMD with the patient's EHR in order to create a dataset. According to one embodiment, the clinician device is a personal computer or tablet having a software application for the purposes of the present invention. For example, the software application is a web-based browser application. 【0013】 According to one embodiment of the medical device system of the present invention, the plurality of parameters include at least one of IMD device parameters, patient-associated physiological parameters, and / or patient-associated functional parameters. 【0014】 Firstly, multiple parameters help assess whether the IMD is implanted. These parameters are acquired by a detection unit, which may be equipped with any type of sensor, e.g., sensors for electrical, mechanical, and / or chemical signals. At least one of the parameters can be used to identify whether the IMD is located at the implantation site. For example, possible signal types for this purpose include electrical signals (potentials, electrocardiograms such as (subcutaneous) electrocardiograms (ECG(s), electroencephalograms), electromyograms (EEG), electromyograms (EMG), evoked composite action potentials (eCAP), impedance values, etc.), accelerometer signals, photoplethysmography signals, pH signals, etc. The measured signals can be analyzed by comparison with a reference signal and / or threshold to identify the implanted state. If the IMD is a cardiac stimulator, the IMD may measure potentials at the sensing and / or stimulating electrodes to derive ECG and / or lead impedance measurements. The ECG can be compared to the reference signal characteristics of the ECG, and the lead impedance value is assessed to determine if it is within the acceptable range for an implanted cardiac stimulator lead. If at least one or both of these conditions are met, the IMD identifies that it is in an implanted state. Alternatively, the parameters are sent to a programming device communicating with the IMD, which performs an evaluation of at least one parameter. In this case, the programming device informs the IMD whether it is in an implanted state. Secondly, multiple parameters are used by an external server to generate a dataset. At least one parameter used for this purpose may be the same as that used for the first purpose, or it may include further information, for example, about the state of the IMD device and programming parameters. For example, such further information may include the state of the IMD battery, the state of connection to the stimulation leads, the state of wireless connection to an external device, and the set of programming parameters currently activated. 【0015】 Furthermore, according to one embodiment, the telemetry unit is configured to send at least one of a plurality of parameters to a relay device, and the relay device is configured to send at least one of the plurality of parameters to an external server. 【0016】 IMDs are typically limited in terms of battery capacity and device volume. To conserve both, a viable option is to outsource the computing process outside the IMD. For example, an IMD can be configured to send acquired data to an external device or server for further processing. Furthermore, instead of sending acquired data to an instance located far from the IMD, the IMD can send the data to a relay device located close to the IMD. In this embodiment, the IMD may send data to the relay device at a low energy cost, for example, via a first wireless communication technique. The relay device then transfers the data to an external server, and because the distance from the relay device to the external server is long, or because the transfer needs to be done via a local or wide area network, the transfer may consume more energy compared to sending from the IMD to the relay device. According to one embodiment, the data transmission from the relay device to the external server may be performed via a second wireless communication technique different from the first wireless communication technique. 【0017】 According to a preferred embodiment of the medical device system of the present invention, the dataset includes a process proposal. The process proposal includes information relating to at least one of the following: patient discharge, programming changes to the IMD, further treatment of the patient, or initiation of a service of a separate medical device or a separate external server. 【0018】 According to the embodiment, the process suggestion should serve as information to clinical staff to suggest the next steps in the actions associated with the IMD and / or the patient holding the IMD. Typically, after IMD implantation, the patient requires a visit by a clinician to query the IMD with a programmer device to obtain IMD device and / or patient data, thereby deriving the next steps to be performed for the IMD and / or the patient. The proposed medical device system can replace such visits and queries with an automated process that takes place in the background by remote data processing and transmission. If at least one parameter transmitted from the IMD to an external server does not indicate an abnormality, meaning the patient is in an acceptable state and the IMD is functioning properly with appropriate programming parameters for the patient, the process suggestion includes a suggestion to discharge the patient from the clinic. Alternatively, if at least one parameter indicates that the treatment provided to the patient by the IMD is not optimal, the external server performs further analysis on the data obtained from the IMD to investigate programming changes to the IMD and / or further treatment of the patient for treatment optimization. For example, programming changes may include modifications to the therapeutic amplitude, frequency, pulse width, duty cycle, stimulation threshold, stimulation electrode, stimulation waveform, sensitivity, etc., for any type of stimulation therapy. For example, if the IMD is some kind of drug pump, programming changes may include modifications to the drug dosage, frequency, time pattern, etc. According to one embodiment, further treatment of the patient may include procedures performed in the clinic, such as further clinic stays for the patient for further monitoring, examination of the IMD or components of the IMD (e.g., stimulation leads) in case of abnormalities in at least one parameter, and additional medication for the patient. According to one embodiment, the process proposal may include activating a service on a separate medical device or a separate external server. An exemplary service is a remote monitoring service for IMD parameters and / or patient parameters.In the case of cardiac stimulation devices, these can be services for overall remote monitoring of cardiac parameters, or specifically for heart failure monitoring, or for monitoring IMD parameters as stimulation parameters or lead impedance. For any type of device, remote monitoring of patient parameters considering the patient's general health should be considered, thereby allowing for the inclusion of additional patient data from additional sources other than the IMD, such as from other IMDs, or additional patient data from patient devices that track the patient's environmental data or record other physical or mental data of the patient. As an example, data from the patient's smartphone, which is used by the patient to input information about general health, sleep quality, mental state, physical health, etc., can be used for this purpose. 【0019】 Furthermore, according to one embodiment, the external server is configured to send the dataset to the advisor device before sending it to the clinician device. 【0020】 In this embodiment, the dataset is first sent by an external server to an advisor device and then transferred to a clinician device. This additional step allows for an intermediate check of the dataset by the advisor device before final submission to the clinician device. The advisor device can be, for example, a server or device that allows an advisor to review the dataset. For example, the advisor is a representative of an IMD manufacturer or a service personnel for remote management of an IMD. According to one embodiment, the advisor device is a personal computer or tablet having a software application for the purposes of the present invention. For example, the software application is a web-based browser application. According to one embodiment, the advisor device and the external server are based on a single server platform. Being based on a single server platform is understood to mean that a single server platform is involved in all data transfers associated with the advisor device and the external server, and all data processing associated with the advisor device and the external server is performed on a single server platform. 【0021】 Preferably, according to one embodiment, the external server is configured to wait for a response from the advisor device before initiating transmission of the dataset to the clinician device. In this case, the advisor device may function as a review stage before the dataset is finally transmitted to the clinician device by the external server. Implementing an additional review stage improves the reliability of the dataset's contents. 【0022】 According to one embodiment of the present invention, the advisor device is configured to send a response to an external server, the response including confirmation of a dataset, or the response including a modified dataset. 【0023】 As described above, the additional review stage represented by the advisor device enhances the overall reliability of the content contained in the dataset. The advisor device may have different options for the user to provide feedback to the external server regarding the dataset. For example, a response to the external device may be made that includes a confirmation of the dataset if acceptable, or the response may include a modified dataset that replaces the previous dataset. The advisor device's option to modify the user's dataset has the advantage of improving the workflow efficiency of the post-implantation clinical process for IMDs for patients and clinical staff. According to the latter embodiment, the external server is configured to initiate the transmission of the modified dataset to the clinician device. Specifically, the advisor device sends the modified dataset to the external server, which then forwards the modified dataset to the clinician device. 【0024】 In particular, according to one embodiment of the medical device system of the present invention, the external server is configured to receive approval of a dataset from a clinician device. 【0025】 According to the above embodiment, the clinician device would have received a dataset or a modified dataset from an external server in the previous step. Next, the clinician reviews the dataset on the clinician device. If the clinician agrees to the dataset, the clinician sends approval to the external server via the clinician device. According to one embodiment, the clinician has the option to generate a modified dataset, which is sent to the external server. In that step, if the dataset includes patient discharge without further modification of IMD programming parameters, the clinician and / or clinical staff may initiate the patient's discharge procedure. In that step, if the dataset includes information on further treatment of the patient in the clinic, the clinician and / or clinical staff may initiate the procedure accordingly. Furthermore, the approval is received by the external server and further processed for subsequent steps. 【0026】 In particular, according to one embodiment, the external server is configured to implement operations associated with the dataset upon receiving approval from the clinician device. The associated operations may be as follows according to a specific type of data in the dataset. 【0027】 If necessary, the external server is configured to initiate, for example, all transmissions regarding the patient's discharge or further treatment process to the receiving instance as further discharge information of the patient or further information regarding the patient's treatment to the clinician device. 【0028】 When the dataset includes information regarding a programming change of the IMD, the external server is configured to send the programming change to the IMD. This enables the necessary programming changes to be directly and quickly sent and implemented to the IMD. According to one embodiment, the external server transfers the programming change information to the relay device, the relay device sends the information to the IMD, and the programming change is automatically implemented. 【0029】 When the dataset includes information regarding the activation of a service of a separate medical device or a separate external server, the external server is configured to initiate the activation of such a service. For example, the external server may transfer activation information to the IMD for a specific process and / or notify the service provider of the activation of the service. 【0030】 According to a preferred embodiment, an external server is configured to generate a claim when it receives approval from a clinician device and implements all operations related to the approved dataset. This means, in particular, when processes related to patient discharge, further treatment of the patient, activation of services of a separate medical device or a separate external server, and / or programming changes of the IMD are achieved. The claim may include all claim data associated with the IMD itself that provides related services activated according to the IMD and / or the dataset. Further, according to one embodiment, the external server is configured to send the claim to a clinician device or a clinic procurement instance. The clinic procurement instance can be any kind of remote computing entity for storing, processing, allocating, and transferring data associated with clinic claims. In known workflows, claim issuance is processed by a manual post-implantation procedure by a representative of the IMD manufacturer. According to the above embodiment, the claim issuance process can be executed in the same automated post-implantation workflow, thus being highly automated and improving the overall process efficiency. 【0031】 Further, according to one embodiment of the present invention, an advisor device, an external server, and an instance of a service provider are based on one server platform. According to one embodiment, at least two instances of the advisor device, the external server, and the service provider are based on one server platform. Being based on one server platform is understood such that one server platform is involved in all data transfers associated with the advisor device and the external server or the service provider, and all data processing associated with the advisor device, the external server or the service provider is executed on one server platform. 【0032】 According to one embodiment of the present invention, the IMD is registered by an external server, for example, in the vendor's backend system which is part of the external server, as soon as the clinic receives the IMD, before implantation takes place. Registration can be performed automatically after the clinic places an order, or manually by a representative of the IMD manufacturer. The early registration in the external server allows all automated data transfers and incoming new records associated with the IMD after implantation to be added to the registration file associated with the IMD, thereby enhancing the post-implantation workflow. 【0033】 According to one embodiment of the medical device system of the present invention, the IMD is a cardiac pacemaker, an implantable cardioverter-defibrillator, an implantable cardiac monitor, or a nerve stimulator. Examples of nerve stimulators include deep brain stimulators and spinal cord stimulators. Generally, the IMD by the proposed system can be any type of IMD requiring post-implantation monitoring based on the measurable IMD and / or patient parameters. 【0034】 In embodiments where the IMD is an implantable cardiac pacemaker or implantable defibrillator, the multiple parameters detected by the detection unit are: Intracardiac electrocardiogram (IEGM) and, Average heart rate and, Lead impedance and, Sensing amplitude and, This includes the pacing threshold. 【0035】 Each of the parameters described above may be used by the processing unit to configure the presence of an implanted IMD. Only when an IMD is implanted can the detection unit detect the IEGM or mean heart rate. The lead impedance measured when an IMD is implanted is completely different from the impedance determined by an IMD that is not in the patient's body. The same is true for the sensing amplitude or pacing threshold (there is no sensing or response to pace in the IEGM before implantation). 【0036】 The following subsequent dataset further includes at least one of the above parameters, preferably some of the above parameters, most preferably all of them, and an implant identification number (ID). 【0037】 In one embodiment, the pacing threshold, sensing amplitude, and / or lead impedance may be transmitted to the clinician device in combination with the implant ID. The pacing threshold and / or sensing amplitude are, in most cases, considered by the physician to assess the proper performance of the implanted device. As a result, the dataset transmitted to the clinician device enables the clinician to determine whether the implant is functioning properly and whether the patient can be discharged. 【0038】 The parameters described above may be displayed on the clinician's device as numerical values ​​or risk scores, for example, as an optical signal having white = OK, yellow = Check, and red = No IMD performance. 【0039】 In embodiments where IEG and / or heart rate are part of a dataset sent to the physician, the clinician may be able to not only determine the proper functioning of the implanted device but also check for other underlying conditions. 【0040】 According to one aspect of the present invention, a method for automatically evaluating the state of IMD after implantation is proposed. This method is The steps include detecting multiple parameters using IMD and identifying that an IMD has been implanted in a patient based on at least one of the multiple parameters, Send at least one of several parameters to an external server. The steps include: processing at least one of several parameters by an external server, A step of creating a dataset associated with IMD and / or patients based on at least one of several parameters, This includes the step of initiating the transmission of a dataset to a clinician device. 【0041】 All the variations and embodiments described with respect to the medical device system can be combined in any desired way and can be applied to the described method individually or in any combination. Furthermore, all embodiments and variations of the described method can be combined in any desired way and can be applied to the medical device system individually or in any combination. 【0042】 The various features and advantages of the present invention can be more readily understood by referring to the embodiments shown in the following detailed description and drawings. [Brief explanation of the drawing] 【0043】 [Figure 1] A schematic diagram of an exemplary IMD according to the present invention is shown. [Figure 2a] A schematic diagram of one embodiment of the medical device system of the present invention is shown. [Figure 2b] A schematic diagram of one embodiment of the medical device system of the present invention is shown. [Figure 3] A detailed, exemplary workflow for the automated evaluation of the IMD state according to the present invention is shown. 【0044】 Modes for carrying out the invention Referring to Figure 1, an exemplary IMD1 is shown. The IMD1 comprises a detection unit 2, a processing unit 3, and a telemetry unit 4 that are connected to and communicate with each other. The detection unit 2 is used to sense and detect multiple parameters, for example, via sensors (not shown) for measuring electrical, mechanical, and / or chemical signals. The processing unit 3 is configured to identify that the IMD1 has been implanted in a patient based on at least one of the multiple parameters. Furthermore, the processing unit 3 is configured to transmit at least one of the multiple parameters to an external server via the telemetry unit 4. The telemetry unit 4 typically comprises a telemetry circuit and an antenna (not shown). Depending on the communication technology used for wireless communication, the antenna may be an RF antenna or a coil for inductive communication. 【0045】 Figure 2a schematically shows one embodiment of a medical device system 51 according to the present invention. Patient 20 holds an IMD1 that was previously implanted in a surgical procedure. An IMD1 detection unit 2 is configured to detect a plurality of parameters, and an IMD1 processing unit 3 is configured to identify that the IMD1 has been implanted in patient 20 based on at least one of the plurality of parameters. Alternatively, the IMD1 is notified of this by a programmer device 100 via a communication channel 101 (e.g., via inductive or RF communication). Furthermore, the processing unit 3 is configured to initiate transmission to an external server 30 via a telemetry unit 4 using at least one of the plurality of parameters via a communication channel 21. The external server 30 is configured to process at least one of the plurality of parameters and create a dataset 34 associated with the IMD1 and / or patient 20 based on at least one of the plurality of parameters. The external server 30 is configured to initiate transmission to a clinician device 40 using the communication channel 31 of the dataset 34. 【0046】 Referring to Figure 2b, according to the alternative or addition of the medical device system 52 according to the present invention, the telemetry unit 4 of IMD1 is configured to initiate transmission to relay device 90 using at least one communication channel 91 of a plurality of parameters, and device 90 is configured to initiate transmission to external server 30 using at least one communication channel 92 of a plurality of parameters. 【0047】 Referring to Figure 2a or Figure 2b, before sending the dataset 34 to the clinician device 40, the external server 30 is configured to initiate transmission of the dataset 34 to the advisor device 71 using the communication channel 72. According to this embodiment, the dataset 34 is first sent by the external server 30 to the advisor device 71, where the dataset is reviewed by the advisor 70. For example, the advisor 70 may be a representative of the manufacturer of IMD. The advisor device 71 is configured to respond to the external server 30 by accepting the dataset 34 or by generating a dataset modified by each input of the advisor 70. The dataset 34 or modified dataset is then returned to the external server 30 via the communication channel 72. The external server 30 then sends the dataset 34 or modified dataset to the clinician device 40 via the communication channel 31. The dataset 34 or modified dataset is then reviewed by the clinician 50 on the clinician device 40. The clinician 50 uses the clinician device 40 to input a response to the dataset 34 or modified dataset. The clinician device 40 transmits the input from the clinician 50 to the external server 30 via the communication channel 31. 【0048】 Referring to Figure 2a or Figure 2b, in the next step, the external server 30 is configured to implement an action associated with the dataset 34 upon receiving input (e.g., approval) from the clinician device 40. The associated action may be as follows, according to a specific type of processing proposal: 【0049】 If necessary, the external server 30 is configured to initiate all communication to the receiving instance regarding the patient's discharge or further treatment process for the patient, for example, via the communication channel 31 to the clinician device 40 as further information regarding the patient's discharge or further information regarding the patient's treatment. 【0050】 If the dataset 34 contains information regarding programming changes to IMD1, the external server 30 is configured to transmit the programming changes to IMD1 via communication channel 21 in the embodiment of Figure 2a, or via communication channels 92 and 91 bridged by relay device 90 in the embodiment of Figure 2b. 【0051】 If dataset 34 contains information regarding the startup of a service of a separate medical device or a separate external server, the external server 30 is configured to initiate the startup of such service. For example, the external server 30 may forward startup information to IMD1 for a particular process via communication channel 21 in the embodiment of Figure 2a, or via communication channels 92 and 91 bridged by relay device 90 in the embodiment of Figure 2b. Alternatively or additionally, the external server 30 may forward startup information to the service provider 80 of the startup of the service via communication channel 33. 【0052】 According to a preferred embodiment, the external server 30 is configured to generate an invoice 35 upon receiving approval from the clinician device 40 and to send the invoice 35 to the clinician device 40 via communication channel 31 or to the clinic procurement instance 60 via communication channel 32. 【0053】 Referring to Figure 2a or Figure 2b, according to one embodiment of the present invention, IMD1 is registered by an external server 30, for example, with a vendor backend system which is part of the external server, as soon as the clinic receives IMD1, before implantation is performed. Registration can be performed automatically after the clinic places an order, or it can be performed manually by a representative of the IMD manufacturer, for example, an advisor 70. The early registration in the external server 30 allows all automated data transfers and incoming new records associated with the IMD after implantation to be added to the registration file 36 associated with IMD1, thereby enhancing the post-implantation workflow. 【0054】 Figure 3 shows a detailed exemplary workflow for the automated evaluation of the IMD status according to the present invention. 【0055】 A1) As soon as it is determined that the clinic has received IMD1, it is registered with the external server 30, more specifically with the vendor backend system of the external server 30. Registration can be performed automatically after the order has been placed by the clinic, or it can be performed manually by a representative of the IMD manufacturer 70. 【0056】 A2) A representative 70 of the IMD manufacturer provides IMD1 to the clinic's contracted warehouse 301. 【0057】 B) For implantation, the clinical staff / clinicians 50 retrieve IMD1 from the consigned warehouse 301. 【0058】 C) Clinician 50 implants IMD1 in the patient. 【0059】 D) IMD1 automatically detects that it is implanted (or that this has been notified by the programmer device) and records a set of parameters that enable it to be described with respect to the following characteristics: a) Technical functions of IMD1 b) IMD1 function related to patients c) Patient status (e.g., ECG(s) for implantable cardiac monitors, intracardiac ECG for cardiac pacemakers and implantable cardioverter-defibrillators) 【0060】 E) Rapid transmission of the parameter set to the external server 30 as a follow-up message after detection of the implanted state, either directly or via any relay device or patient device (it does not need to be registered / activated / assigned to the patient in advance for this purpose). 【0061】 F) The external server 30 processes the parameter set and creates a dataset. The external server 30 is connected to the clinic's electronic health record (EHR) system 302 and synchronizes the data from IMD1 with the patient's EHR to create a dataset. 【0062】 G) Representatives of IMD manufacturers will be notified. 【0063】 H) A representative 70 of the IMD manufacturer remotely reviews / verifies / corrects the dataset and sends it back to the external server 30. 【0064】 I) The clinical staff / clinicians will be notified. 【0065】 J) Clinical staff / clinicians 50 remotely review / verify / correct the dataset and send it back to the external server 30. 【0066】 K) The external server 30 starts the program for IMD1 according to the dataset. 【0067】 L) The external server 30 sends the program to IMD1. 【0068】 M) The external server 30 sends billing data (including additionally started services) to the clinic procurement instance 60. [Explanation of Symbols] 【0069】 1 IMD 2 detection units 3 Processing Units 4 Telemetry Units 51, 52 Medical device systems 20 patients Communication channels 21, 31, 32, 33, 72, 91, 92, 101 30 External Servers 34 datasets 35 Invoice 36 Registration File 40 Clinician Devices 50 Clinical Staff / Clinicians 60 Clinic Procurement Instances 70 Advisors / Representatives of IMD manufacturers 71 Advisory Devices 80 Service Providers 90 relay devices 100 programmer devices 301 Consignment warehouse 302 Clinic Electronic Health Record (EHR) System

Claims

[Claim 1] A medical device system (5), An implantable medical device (IMD, 1) comprising a detection unit (2), a processing unit (3), and a telemetry unit (4), External server (30), A clinician device (40) is provided, The detection unit (2) of the IMD (1) is configured to detect a plurality of parameters, and the processing unit (3) is configured to identify that the IMD (1) has been implanted in a patient (20) based on at least one of the plurality of parameters. The processing unit (3) is configured to transmit at least one of the plurality of parameters to the external server (30) via the telemetry unit (4). Medical device system (5), wherein the external server (30) is configured to process at least one of the plurality of parameters, the external server (30) is configured to create a dataset (34) associated with the IMD (1) and / or the patient (20) based on at least one of the plurality of parameters, the dataset (34) includes at least one piece of information for making a decision associated with the IMD (1) and / or the patient (20), and the external server (30) is configured to initiate the transmission of the dataset (34) to the clinician device (40). [Claim 2] The medical device system (5) according to claim 1, wherein the plurality of parameters include at least one IMD(1) device parameter, at least one physiological parameter associated with the patient (20), and / or at least one functional parameter associated with the patient (20). [Claim 3] The medical device system (5) according to claim 1 or 2, wherein the telemetry unit (4) is configured to transmit at least one of the plurality of parameters to a relay device (90), and the relay device (90) is configured to transmit at least one of the plurality of parameters to an external server (30). [Claim 4] The dataset (34) includes a process proposal, and the process proposal is The discharge of the aforementioned patient (20), Programming change of the IMD(1) and Further treatment of the aforementioned patient (20), A medical device system (5) according to at least one of claims 1 to 3, comprising information relating to the initiation of at least one of: a separate medical device or a service on a separate external server. [Claim 5] The medical device system (5) according to at least one of claims 1 to 4, wherein the external server (30) is configured to transmit the dataset (34) to the advisor device (71) before transmitting the dataset (34) to the clinician device (40). [Claim 6] The medical device system (5) according to claim 5, wherein the external server (30) is configured to wait for a response from the advisor device (71) before starting the transmission of the dataset (34) to the clinician device (40). [Claim 7] The medical device system (5) according to claim 5 or 6, wherein the advisor device (71) is configured to send a response to the external server (30), the response including confirmation of the dataset (34) or the response including a modified dataset. [Claim 8] The medical device system (5) according to claim 7, wherein the external server (30) is configured to initiate the transmission of the modified dataset to the clinician device (40). [Claim 9] The medical device system (5) according to at least one of claims 1 to 8, wherein the external server (30) is configured to receive approval for the dataset (34) from the clinician device (40). [Claim 10] The medical device system (5) according to claim 9, wherein the external server (30) is configured to implement the operation associated with the dataset (34) when it receives the approval from the clinician device (40). [Claim 11] The medical device system (5) according to claim 9 or 10, with reference to claim 4, wherein the external server (30) is configured to transmit the programming changes to the IMD (1) if the dataset (34) contains information relating to programming changes to the IMD (1). [Claim 12] The medical device system (5) according to any one of claims 10 to 11, wherein the external server (30) is configured to generate an invoice (35) when it receives the approval from the clinician device (40) and implements all operations related to the approved dataset. [Claim 13] The medical device system (5) according to claim 12, wherein the external server (30) is configured to transmit the invoice (35) to the clinician device (40) or the clinic procurement instance (60). [Claim 14] The medical device system (5) according to any one of claims 1 to 13, wherein the IMD (1) is a cardiac pacemaker, an implantable cardioverter-defibrillator, an implantable cardiac monitor, or a nerve stimulator. [Claim 15] A method for automatically evaluating the condition of an implantable medical device (IMD, 1) after implantation, The steps include detecting a plurality of parameters using the IMD(1) and identifying that the IMD(1) has been implanted in a patient (20) based on at least one of the plurality of parameters, At least one of the aforementioned multiple parameters is sent to an external server (30), The steps include processing at least one of the multiple parameters by the external server (30), A step of creating a dataset (34) associated with the IMD (1) and / or the patient (20) based on at least one of the plurality of parameters, wherein the dataset (34) includes at least one piece of information for making a decision associated with the IMD (1) and / or the patient (20); A method comprising the step of initiating the transmission of the dataset (34) to a clinician device (40).

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