WO2024251605A1 - Système de dispositif médical et procédé d'évaluation automatisée d'un état de dispositif médical implantable - Google Patents

Système de dispositif médical et procédé d'évaluation automatisée d'un état de dispositif médical implantable Download PDF

Info

Publication number
WO2024251605A1
WO2024251605A1 PCT/EP2024/064910 EP2024064910W WO2024251605A1 WO 2024251605 A1 WO2024251605 A1 WO 2024251605A1 EP 2024064910 W EP2024064910 W EP 2024064910W WO 2024251605 A1 WO2024251605 A1 WO 2024251605A1
Authority
WO
WIPO (PCT)
Prior art keywords
imd
external server
data set
parameters
medical device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/064910
Other languages
English (en)
Inventor
Joachim Elsner
Jürgen KÖPPEL
Thorsten WENZLAFF
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biotronik SE and Co KG
Original Assignee
Biotronik SE and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biotronik SE and Co KG filed Critical Biotronik SE and Co KG
Priority to CN202480034678.3A priority Critical patent/CN121219046A/zh
Publication of WO2024251605A1 publication Critical patent/WO2024251605A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3706—Pacemaker parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37282—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data characterised by communication with experts in remote locations using a network

Definitions

  • BIOTRONIK SE & Co. KG Applicant: BIOTRONIK SE & Co. KG
  • the invention relates to medical device systems and methods for automated evaluation of the status of an implantable medical device (IMD) directly after implantation of the IMD in a patient.
  • IMD implantable medical device
  • the invention involves an external server which 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 invention enables automated analysis of the IMD status and of the status of a patient after the implantation procedure and facilitates in-clinic workflows.
  • Implantable medical devices are used in various therapy applications to ensure a reliable treatment of a patient’s condition. Some IMDs have the capability to deliver therapy and to sense device parameters and/or patient parameters using sensing components and/or sensing devices.
  • an IMD is implanted in a surgery procedure, followed by the patient staying in the hospital for observation.
  • a final examination needs to be performed by a clinician, including checks of the IMD device parameters, and patient parameters sensed by the IMD. Said checks are for instance carried out by establishing a communication connection between the IMD and programmer device via inductive coupling, whereby the parameters of interest are retrieved by the programmer via said communication connection.
  • the clinician decides on a reprogramming of the IMD, and/or a discharge of the patient.
  • Invoicing for the IMD follows in an independent process, which is initiated by the clinic or an IMD manufacturer representative at the clinic.
  • the present workflow comprises several manual steps, requiring an in-office visit of the clinician and usage of the IMD programming device. Moreover, invoicing for the IMD and related services is treated as a standalone process, requiring further manual steps.
  • a medical device system comprising an implantable medical device (IMD), wherein the IMD comprises a detection unit, a processing unit and a telemetry unit, an external server, and a clinician device.
  • IMD implantable medical device
  • the IMD comprises a detection unit, a processing unit and a telemetry unit, an external server, and a clinician device.
  • the detection unit of the IMD is configured to detect a plurality of parameters
  • the processing unit of the IMD is configured to identify that the IMD is implanted in a patient based on at least one of the plurality of parameters.
  • the processing unit is configured to transmit at least one of the plurality of parameters to the external server via the telemetry unit.
  • the external server is configured to process the at least one of the plurality of parameters, and to create a data set associated with the IMD and/or with the patient based on the at least one of the plurality of parameters.
  • the data set comprises at least one information for taking a decision associated with the IMD and/or associated with the patient.
  • the external server is configured to initiate the transmission of the data set to the clinician device.
  • the proposed medical device system solves the described problem by providing an automated workflow for evaluation of an IMD status after the implantation procedure.
  • IMDs are devices which provide at least one diagnostic or therapeutic function to the human or animal body, and which are configured to be inserted at least in part into the same.
  • the IMD according to the invention comprises a detection unit, a processing unit, and a telemetry unit.
  • the detection unit can comprise a sensor of any kind, for instance a sensor for electrical, mechanical and/ or chemical signals.
  • the processing unit is configured to process the detected signals and to derive and execute resulting actions for the IMD.
  • the telemetry unit is configured to wirelessly transmit and receive data to and from the IMD. First, the IMD itself will detect or identify an implanted state directly after implantation.
  • the processing unit initiates the telemetry unit to transmit the at least one parameter to the external server.
  • the external server can be any kind of remote computational entity for storing, processing, allocating and forwarding data.
  • the at least one parameter is analyzed by means of the external server, e.g., by comparison with reference values or threshold values and/or analysis of the parameter in the context of further patient data.
  • an artificial intelligence model may be fed with a large amount of training data, in particular data from IMDs and data from patients who carry an IMD or just received an IMD.
  • training data may be collected from IMDs by interrogation using a programmer device, or via remote monitoring, in particular technical data or data on the functionality of the IMD in association with a patient.
  • Training data from the patient can be collected via sensors of the IMD (e.g. ECG data) or other sensors.
  • An amount of training data useful for identifying IMD and/or patient states may evolve over time subject to analytics applied to ongoing data collection efforts applied across a pool of patients implanted with such IMDs.
  • the collection of information may be supported by any one of multiple possible avenues including but not limited to mechanisms that relay the status of patient and device conditions to wearables, mobile devices, or bedside units that can pass data further on to centralized repositories.
  • Artificial intelligence-based surveys of a growing body of information collected from the pool of patients may serve to enhance the predictability and accuracy of IMD states and/or patient states after implantation.
  • a data set will be generated based on the analysis of the at least one parameter.
  • the data set is understood as a set of data which include a proposal for one subsequent action associated with the patient and/or the IMD.
  • the external server will then initiate the transmission of the data set to the clinician device.
  • the clinician device is understood as any device which is at least capable of informing a clinician of the data set.
  • the data set comprises at least one information for taking a decision associated with the IMD and/or associated with the patient.
  • the clinician reviews the data set on the clinician device, and uses the data set as basis for deciding on further steps in association with the IMD and/or the patient.
  • the clinician device provides an access for a clinician by an authentication stage.
  • the clinician device provides means to interrogate the IMD and change at least one programming parameter of the IMD.
  • the external server is connected to the electronic health record (EHR) system of the clinic to synchronize the data from the IMD with the EHR of the patient for creating the data set.
  • the clinician device is a personal computer or a tablet having a software application for the purpose according to the invention.
  • the software application is a web based browser application.
  • the plurality of parameters comprises at least one of a IMD device parameter, a physiological parameter associated with the patient, and/or a functional parameter associated with the patient.
  • the plurality of parameters serves for evaluating whether the IMD is in an implanted state.
  • the plurality of parameters is obtained by the detection unit, wherein the detection unit can comprise a sensor of any kind, for instance a sensor for electrical, mechanical and/ or chemical signals.
  • At least one of the parameters can be used to identify whether IMD is located at the implantation site.
  • considered types of signals for this purpose are electrical signals (electrical potentials, electrograms like (subcutaneous) electrocardiograms (s)ECG, electroencephalograms EEG, electromyograms EMG, evoked compound action potentials eCAPs, impedance values, etc.), accelerometer signals, photoplethysmography signals, pH signals, or the like.
  • the measured signals can be analyzed by comparison to reference signals and/or thresholds to identify an implanted state.
  • the IMD may measure the electric potentials at sensing and/or stimulation poles for deriving ECGs and/or lead impedance measurements.
  • the ECGs can be compared to reference signal characteristics of ECGs, and the lead impedance values are evaluated to be in an acceptable range for implanted cardiac stimulation leads. If at least one of these or both applies, the IMD will identify that it is in an implanted state.
  • the parameters will be sent to a programming device which is in communication with the IMD, wherein the programming device performs the evaluation of the at least one parameter.
  • the programming device will communicate to the IMD whether the IMD is in an implanted state.
  • the plurality of parameters is used by the external server to generate the data set.
  • the at least one parameter used for that purpose can be the same as for the first purpose, or include further information, e.g., on the IMD device status and programming parameters.
  • further information may comprise the IMD battery status, the status of connections to stimulation leads, the status of wireless connections to external devices, the set of currently activated programming parameters, etc.
  • the telemetry unit is configured to transmit at least one of the plurality of parameters to a relay device, wherein the relay device is configured to transmit the at least one of the plurality of parameters to the external server.
  • IMDs are typically limited in terms of battery capacity and device volume. For saving both, an effective option is outsourcing of computational processes outside of an IMD.
  • the IMD can be configured to transmit acquired data to an external device or an external server for further processing.
  • the IMD can transmit the data to a relay device in close proximity to the IMD.
  • the IMD may transmit the data with low energy costs to the relay device, for instance via a first wireless communication technique.
  • the relay device forwards the data to the external server, which may consume a higher amount of energy compared to the transmission from IMD to relay device due to the greater distance from the relay device to the external server or due to the need to forward via local or wide area networks.
  • the data transmission from the relay device to the external server may be performed via a second wireless communication technique which is different from the first wireless communication technique.
  • the data set comprises a process proposal.
  • the process proposal includes information regarding at least one of a discharge of the patient, a programming change of the IMD, a further treatment of the patient, or an activation of a service of a separate medical device or separate external server.
  • the process proposal should serve as information to the clinical staff to propose a next step of actions associated with the IMD and/or with the patient who carries the IMD.
  • the patient Normally, after implantation of the IMD, the patient requires a visit by the clinician who interrogates the IMD with a programmer device to acquire IMD device and/or patient data to derive the next step to perform to the IMD and/or the patient.
  • the proposed medical device system allows to replace said visit and interrogation by an automated process which happens in the background by remote data processing and transmission.
  • the process proposal will include a suggestion to discharge the patient from the clinic.
  • the external server will perform further analysis on the acquired data from the IMD to investigate on a programming change of the IMD for therapy optimization, and/or a further treatment of the patient.
  • the programming change may include a change of a therapy amplitude, frequency, pulse width, duty cycle, stimulation threshold, stimulation electrode, stimulation waveform, sensitivity, or the like, for any kind of stimulation therapy.
  • the programming change may include a change of medication dosage, frequency, time pattern, or the like.
  • the further treatment of the patient may include a procedure to be performed in the clinic, as for instance a further in-clinic stay of the patient for further monitoring, a checkup of the IMD or components of the IMD (e.g., stimulation leads) in case of anomalies in the at least one parameter, additional medication for the patient, or the like.
  • the process proposal can comprise an activation of a service of a separate medical device or separate external server. Exemplary services are remote monitoring services of the IMD parameters and/ or patient parameters.
  • cardiac stimulation devices these can be services for overall remote monitoring of cardiac parameters, or in particular heart failure monitoring services, monitoring of IMD parameters as stimulation parameters or lead impedances.
  • remote monitoring of the patient parameters in view of the general well-being of the patient are to be considered, whereby additional patient data from additional sources different from the IMD can be consulted, e.g., from other IMDs, or from a patient device which tracks environmental data of the patient or which records other physical or mental data of the patient.
  • data from a patient smartphone can be used for that purpose, which is used by the patient to enter their information on general well-being, sleep quality, mental state, physical fitness or the like.
  • the external server prior to transmission of the data set to the clinician device, is configured to transmit the data set to an advisor device.
  • the data set is first transmitted by the external server to an advisor device, and then forwarded to the clinician device.
  • the advisor device can be for instance a server or a device which allows advisor personnel to review the data set.
  • the advisor personnel is a representative of the IMD manufacturer, or service personnel for remote management of the IMD.
  • the advisor device is a personal computer or a tablet having a software application for the purpose according to the invention.
  • the software application is a web based browser application.
  • the advisor device and the external server are based on one server platform. Being based on one server platform is understood in a way that one 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 the one server platform.
  • the external server is configured to wait for a response from the advisor device prior to initiating the transmission of the data set to the clinician device.
  • the advisor device may serve as review stage before the data set is sent finally to the clinician device by the external server. By implementing an additional reviewing stage, the reliability of the contents of the data set is increased.
  • the advisor device is configured to transmit a response to the external server, wherein the response comprises a confirmation of the data set, or wherein the response comprises an amended data set.
  • an additional reviewing stage represented by the advisor device increases the overall reliability of the contents included in the data set.
  • the advisor device may have different options for a user to provide feedback to the external server in regards of the data set. For instance, a response to the external device can be created which comprises a confirmation of the data set if it is acceptable, or the response comprises an amended data set which replaces the former data set.
  • the option of amending the data set for the user of the advisor device has the advantage of increasing the workflow efficiency for the clinical processes after implantation of the IMD for the patient and the clinical staff.
  • the external server is configured to initiate the transmission of the amended data set to the clinician device.
  • the advisor device will transmit the amended data set to the external server, whereupon the external server forwards the amended data set to the clinician device.
  • the external server is configured to receive an approval for the data set from the clinician device.
  • the clinician device would have received in a previous step the data set or the amended data set from the external server.
  • a clinician reviews the data set on the clinician device. If the clinician agrees to the data set, he or she would send an approval via the clinician device to the external server.
  • the clinician has the option to generate an amended data set, wherein the amended data set is sent to the external server. If in that step the data set comprises the discharge of a patient without further amendments to the IMD programming parameters, the clinician and/ or the clinical staff may initiate a discharge procedure for the patient. If in that step the data set comprises information of a further treatment of the patient in the clinic, the clinician and/ or the clinical staff may initiate the procedures accordingly.
  • the approval is received by the external server and further processed for the subsequent steps.
  • the external server is configured to implement the actions associated with the data set upon receiving the approval from the clinician device.
  • the associated actions may be, according to the specific type of data of the data set:
  • the external server is configured to initiate all the communication related to a discharge of a patient or further treatment processes for a patient to the receiving instances, as for instance further discharging information or further information on treatment of the patient to the clinician device.
  • the external server is configured to transmit the programming change to the IMD. This allows for a quick transmission and implementation of necessary programming changes directly to the IMD. According to an embodiment, the external server forwards the programming change information to the relay device, wherein the relay device transmits the information to the IMD, where the programming changes are implemented automatically.
  • the external server is configured to initiate the activation of such services. For example, the external server may forward activation information to the IMD for a certain process, and/or inform the provider of the service of the activation of said service.
  • the external server is configured to generate an invoice upon receiving the approval from the clinician device, and implementing all actions related with the approved data set. This means in particular, when the processes related to a patient discharge, a further treatment of the patient, an activation of a service of a separate medical device or separate external server, and/or the programming change of an IMD have been accomplished.
  • the invoice may include all billing data associated with the IMD itself, providing the IMD and/or related services which shall be activated according to the data set.
  • the external server is configured to transmit the invoice to the clinician device or a clinic procurement instance.
  • a clinic procurement instance can be any kind of remote computational entity for storing, processing, allocating and forwarding data associated with the clinic billing.
  • invoicing is handled by a manual procedure after implantation by a representative of the IMD manufacturer.
  • the process of invoicing can be carried out in the same after-implantation automated workflow, therefore be automatized to a high degree, enhancing the overall process efficiency.
  • the instances of the advisor device, the external server and the provider of the service are based on one server platform.
  • at least two instances of the advisor device, the external server and the provider of the service are based on one server platform. Being based on one server platform is understood in a way that one server platform is involved in all data transfers associated with the advisor device, the external server or the provider of the service, and all data processing associated with the advisor device, the external server or the provider of the service is performed on the one server platform.
  • an IMD is registered by the external server, for instance in a vendor backend system which is part of the external server, as soon as a clinic receives the IMD, before the implantation takes place.
  • the registration can be performed automatically after an order has been placed by the clinic, or it can be carried out manually by a representative of the IMD manufacturer.
  • IMD is a cardiac pacemaker, an implantable cardioverter-defibrillator, an implantable cardiac monitor or a neurostimulator.
  • neurostimulators are deep brain stimulators, spinal cord stimulators, or the like.
  • the IMD according to the proposed system can be any kind of IMD where an after-implantation checkup procedure, based on measurable IMD and/or patient parameters, is necessary.
  • the IMD is an implantable cardiac pacemaker or an implantable cardioverter-defibrillator the plurality of parameters detected by the detection unit comprise:
  • IEGM intracardiac electrogram
  • Each parameter mentioned above may be used by the processing unit to configure the IMD is implanted. Only if the IMD is implanted the detection unit would be able to detect an IEGM or an average heart rate. The lead impedance measured if the IMD is implanted is completely different from an impedance determined in an IMD which is not within a patient. Same applies to sensing amplitude or pacing threshold (there would be no sense or response to a pace in an IEGM prior implantation).
  • the following subsequent data set would comprise at least one of the above parameters, preferably several, most preferred all of the above, mentioned parameters and an implant identification number (ID) in addition.
  • ID implant identification number
  • the pacing threshold, the sensing amplitude and/or the lead impedance in combination with an implant ID may be transmitted to the clinician device.
  • Pacing threshold and/or sensing amplitude are mostly considered by physicians to evaluate proper performance of the implanted device. Consequently, the data set transmitted to the clinician device enables the clinician to decide whether the implant functions properly and the patient could be sent home.
  • the clinician may be able to not only determine proper function of the implanted device but to check for other underlying diseases as well.
  • a method for automated evaluation of an IMD status after implantation comprises the steps of:
  • All variants and embodiments described with respect to the medical device system can be combined in any desired way and can be transferred either individually or in any arbitrary combination to the described method. Furthermore, all embodiments and variants of the described method can be combined in any desired way and can be transferred either individually or in any arbitrary combination to the medical device system.
  • Fig. 1 shows a schematic illustration of an exemplary IMD according to the invention
  • Fig. 2a shows a schematic illustration of an embodiment of the inventive medical device system
  • Fig. 2b shows a schematic illustration of an embodiment of the inventive medical device system
  • Fig. 3 shows a detailed exemplary workflow for automated evaluation of an IMD status according to the invention.
  • IMD 1 comprises a detection unit 2, a processing unit 3 and a telemetry unit 4, which are connected and in communication with each other.
  • Detection unit 2 is used to sense detect a plurality of parameters, for instance via sensors (not shown) for measuring electrical, mechanical and/or chemical signals.
  • the processing unit 3 is configured to identify that IMD 1 is implanted in a patient based on at least one of the plurality of parameters.
  • processing unit 3 is configured to transmit at least one of the plurality of parameters to the external server via the telemetry unit 4.
  • Telemetry unit 4 typically comprises of a telemetry circuit and an antenna (not shown). Depending on the communication technology used for wireless communication, the antenna can be an RF antenna or a coil for inductive communication.
  • Fig. 2a shows schematically an embodiment of the medical device system 51 according to the invention.
  • Patient 20 carries an IMD 1 which has been previously implanted in an operative procedure.
  • the detection unit 2 of IMD 1 is configured to detect a plurality of parameters
  • the processing unit 3 of IMD 1 is configured to identify that IMD 1 is implanted in the patient 20 based on at least one of the plurality of parameters.
  • the IMD 1 is informed of this by a programmer device 100 via a communication channel 101 (e.g. via inductive communication or RF communication).
  • processing unit 3 is configured to initiate a transmission using a communication channel 21 of at least one of the plurality of parameters to an external server 30 via telemetry unit 4.
  • External server 30 is configured to process the at least one of the plurality of parameters, and to create a data set 34 associated with IMD 1 and/or with the patient 20 based on the at least one of the plurality of parameters. External server 30 is configured to initiate a transmission using a communication channel 31 of the data set 34 to the clinician device 40.
  • telemetry unit 4 of IMD 1 is configured to initiate a transmission using a communication channel 91 of at least one of the plurality of parameters to a relay device 90, wherein relay device 90 is configured to initiate a transmission using the communication channel 92 of the at least one of the plurality of parameters to external server 30.
  • external server 30 prior to transmission of data set 34 to clinician device 40, external server 30 is configured to initiate a transmission using communication channel 72 of data set 34 to an advisor device 71.
  • the data set 34 is first transmitted by the external server 30 to advisor device 71, where the data set is reviewed by advisor personnel 70.
  • advisor personnel 70 can be a representative of the IMD manufacturer.
  • the advisor device 71 is configured to respond to the external server 30 by accepting the data set 34 or by generating an amended data set by respective input of the advisor personnel 70.
  • the data set 34 or amended data set is returned to external server 30 via communication channel 72.
  • the external server 30 will then transmit the data set 34 or the amended data set via communication channel 31 to clinician device 40.
  • the data set 34 or the amended data set will be reviewed by clinician 50 on clinician device 40.
  • Clinician 50 will input a response to data set 34 or the amended data set using the clinician device 40.
  • the clinician device 40 transmits the input of the clinician 50 via communication channel 31 to the external server 30.
  • the external server 30 is configured to implement the actions associated with the data set 34 upon receiving input (e.g. an approval) from clinician device 40.
  • the associated actions may be, according to the specific type of processing proposal:
  • the external server 30 is configured to initiate all the communication related to a discharge of a patient 20 or further treatment processes for a patient 20 to the receiving instances, as for instance further discharging information or further information on treatment of the patient 20 to the clinician device 40 via communication channel 40.
  • the data set 34 comprises information regarding a programming change of IMD 1
  • the external server 30 is configured to transmit the programming change to the IMD 1 via communication channel 21 in the embodiment of Fig. 2a, or via communication channel 92 and 91 bridged by the relay device 90 in the embodiment of Fig. 2b.
  • the external server 30 is configured to initiate the activation of such services.
  • the external server 30 may forward activation information to the IMD 1 for a certain process via communication channel 21 in the embodiment of Fig. 2a, or via communication channel 92 and 91 bridged by the relay device 90 in the embodiment of Fig. 2b.
  • the external server 30 may forward activation information to the provider 80 of the service of the activation of said service via communication channel 33.
  • the external server 30 is configured to generate an invoice 35 upon receiving the approval from the clinician device 40, and to transmit the invoice 35 to the clinician device 40 via communication channel 31, or to a clinic procurement instance 60 via communication channel 32.
  • IMD 1 is registered by the external server 30, for instance in a vendor backend system which is part of the external server, as soon as a clinic receives the IMD 1, before the implantation takes place.
  • the registration can be performed automatically after an order has been placed by the clinic, or it can be carried out manually by a representative of the IMD manufacturer, for example the advisor personnel 70.
  • all automated data transfers and incoming new records associated with the IMD after implantation can be added to the registration file 36 associated with the IMD 1, which enhances the after-implantation workflow.
  • Fig. 3 shows a detailed exemplary workflow for automated evaluation of an IMD status according to the invention.
  • the IMD manufacturer representative 70 provides the IMD 1 to the consignation warehouse 301 of the clinic.
  • the clinical staff / clinician 50 removes the IMD 1 from the consignation warehouse 301.
  • the clinician 50 implants the IMD 1 in the patient.
  • IMD 1 automatically detects that it is in an implanted state (or is informed of this by a programmer device) and records a set of parameters that allow statements to be made about the following properties: a) Technical functionality of the IMD 1 b) functionality of the IMD 1 regarding the patient c) Patient condition (e.g. (s)ECG for an implantable cardiac monitor, intracardiac ECGs for cardiac pacemakers and implantable cardioverter-defibrillators )
  • External server 30 processes the parameter set and creates a data set.
  • the external server 30 is connected to the clinic electronic health record (EHR) system 302 to synchronize the data from the IMD 1 with the EHR of the patient for creating the data set.
  • EHR electronic health record
  • IMD manufacturer representative 70 is notified.
  • IMD manufacturer representative 70 remotely reviews/confirms/revises the data set and returns it to external server 30.
  • Clinical staff / Clinician 50 remotely reviews/confirms/revises data set and returns it to the external server 30.
  • External server 30 activates the program for the IMD 1 according to the data set.
  • External server 30 transmits the program to the IMD 1.
  • External server 30 sends billing data (including any additionally activated services) to the clinic procurement instance 60.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un système de dispositif médical, comprenant un dispositif médical implantable, le dispositif médical implantable comprenant une unité de détection, une unité de traitement et une unité de télémétrie, un serveur externe et un dispositif de clinicien. L'unité de détection du dispositif médical implantable est configurée pour détecter une pluralité de paramètres, et l'unité de traitement du dispositif médical implantable est configurée pour identifier l'implantation du dispositif médical implantable chez un patient sur la base d'au moins un des paramètres de la pluralité de paramètres. En outre, l'unité de traitement est configurée pour transmettre au moins un des paramètres de la pluralité de paramètres au serveur externe par l'intermédiaire de l'unité de télémétrie. Le serveur externe est configuré pour traiter le ou les paramètres de la pluralité de paramètres, et pour créer un ensemble de données associé au dispositif médical implantable et/ou au patient sur la base du ou des paramètres de la pluralité de paramètres. L'ensemble de données comprend au moins une information pour prendre une décision associée au dispositif médical implantable et/ou au patient. De plus, le serveur externe est configuré pour lancer la transmission de l'ensemble de données au dispositif du clinicien.
PCT/EP2024/064910 2023-06-08 2024-05-30 Système de dispositif médical et procédé d'évaluation automatisée d'un état de dispositif médical implantable Pending WO2024251605A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202480034678.3A CN121219046A (zh) 2023-06-08 2024-05-30 用于自动评估可植入医疗设备状态的医疗设备系统和方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23178185.7 2023-06-08
EP23178185 2023-06-08

Publications (1)

Publication Number Publication Date
WO2024251605A1 true WO2024251605A1 (fr) 2024-12-12

Family

ID=86732482

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/064910 Pending WO2024251605A1 (fr) 2023-06-08 2024-05-30 Système de dispositif médical et procédé d'évaluation automatisée d'un état de dispositif médical implantable

Country Status (2)

Country Link
CN (1) CN121219046A (fr)
WO (1) WO2024251605A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002057994A2 (fr) * 2001-01-18 2002-07-25 Medtronic, Inc. Systeme et procede de communication urgente entre un dispositif medical implantable et un systeme informatique pour fournisseur de soins de sante
US20020123778A1 (en) * 1999-10-29 2002-09-05 Medtronic, Inc. Apparatus and method for automated invoicing of medical device systems
EP1241982B1 (fr) * 1999-12-24 2006-10-18 Medtronic, Inc. Systeme logiciel integre destine a l'installation et a la gestion d'un dispositif medical implantable
US20070055324A1 (en) * 2003-11-26 2007-03-08 Thompson David L Multi-mode coordinator for medical device function
US20170128732A1 (en) * 2010-11-12 2017-05-11 Medtronic, Inc. Connectivity detection and type identification of an implanted lead for an implantable medical device
EP4144408A1 (fr) * 2021-09-03 2023-03-08 BIOTRONIK SE & Co. KG Système comprenant au moins un dispositif médical implantable et une installation informatique à distance et procédé de fonctionnement d'un tel système
WO2023046480A1 (fr) * 2021-09-24 2023-03-30 Biotronik Se & Co. Kg Système et procédé d'identification d'implant médical actif

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020123778A1 (en) * 1999-10-29 2002-09-05 Medtronic, Inc. Apparatus and method for automated invoicing of medical device systems
EP1241982B1 (fr) * 1999-12-24 2006-10-18 Medtronic, Inc. Systeme logiciel integre destine a l'installation et a la gestion d'un dispositif medical implantable
WO2002057994A2 (fr) * 2001-01-18 2002-07-25 Medtronic, Inc. Systeme et procede de communication urgente entre un dispositif medical implantable et un systeme informatique pour fournisseur de soins de sante
US20070055324A1 (en) * 2003-11-26 2007-03-08 Thompson David L Multi-mode coordinator for medical device function
US20170128732A1 (en) * 2010-11-12 2017-05-11 Medtronic, Inc. Connectivity detection and type identification of an implanted lead for an implantable medical device
EP4144408A1 (fr) * 2021-09-03 2023-03-08 BIOTRONIK SE & Co. KG Système comprenant au moins un dispositif médical implantable et une installation informatique à distance et procédé de fonctionnement d'un tel système
WO2023046480A1 (fr) * 2021-09-24 2023-03-30 Biotronik Se & Co. Kg Système et procédé d'identification d'implant médical actif

Also Published As

Publication number Publication date
CN121219046A (zh) 2025-12-26

Similar Documents

Publication Publication Date Title
EP2216071B1 (fr) Système pour une programmation de dispositif médical fondée sur des indications
US8298153B2 (en) System and method for the detection of acute myocardial infarction
US8761878B2 (en) Implantable cardiac monitor upgradeable to pacemaker or cardiac resynchronization device
US20100010832A1 (en) System and Method for The Diagnosis and Alert of A Medical Condition Initiated By Patient Symptoms
US9538919B2 (en) System and method for improved ischemia and acute myocardial infarction detection
JP2007535372A (ja) ハンドヘルド式プログラマと埋込可能型医用装置との間の通信方法及び装置
US20110319723A1 (en) System for Characterizing Chronic Physiological Data
US10888702B2 (en) Progressive adaptive data transfer
US8600506B2 (en) Systems and methods for collecting patient event information
US12112848B2 (en) System and method for core-device monitoring
WO2024251605A1 (fr) Système de dispositif médical et procédé d'évaluation automatisée d'un état de dispositif médical implantable
CN114078589B (zh) 医疗随访设备、用于医疗随访的方法、介质和装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24728249

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: CN2024800346783

Country of ref document: CN

WWE Wipo information: entry into national phase

Ref document number: 2024728249

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2024728249

Country of ref document: EP

Effective date: 20260108

ENP Entry into the national phase

Ref document number: 2024728249

Country of ref document: EP

Effective date: 20260108

ENP Entry into the national phase

Ref document number: 2024728249

Country of ref document: EP

Effective date: 20260108

ENP Entry into the national phase

Ref document number: 2024728249

Country of ref document: EP

Effective date: 20260108

ENP Entry into the national phase

Ref document number: 2024728249

Country of ref document: EP

Effective date: 20260108