Patent Application
20250006361
The present invention relates to a computer implemented method for controlling an implantable medical device. Furthermore, the present invention relates a system for controlling an implantable medical device.
Situations such as the COVID-19 pandemic show that an early indication of systemic inflammations is essential to lower the spread and to increase therapy success. Symptoms of COVID-19 are fever, dry cough, fatigue, sputum production, loss of smell, and shortness of breath, which are usually developed between 2 and 14 days after exposure. However, examples show that due to inflammatory processes in the lung the blood oxygen content in the blood may drop slowly, before symptoms are ongoing. This drop is not easily recognized when a patient is in a healthy condition, because it is partly compensated by an increased heart rate in order to fulfill the demand.
One can assume that patients wearing active medical implants like devices in the field of CRM (Cardiac Rhythm Management) such as implantable pacemakers, implantable cardioverter/defibrillators, CRT (Cardiac Resynchronization Therapy) devices or cardiac monitors pertain to a high-risk group of patients when it comes to an increased heart rate.
This condition can be life threatening and needs immediate attention and therapy. Other groups of high risk include patients wearing implantable drug pumps for therapy of chronic diseases like, for example, diabetes, or certain neurological stimulators, like Deep Brain Stimulation (DBS) devices, Vagal Nerve Stimulation (VNS) devices or Spinal Cord Stimulation (SCS) devices.
Currently, there are no existing solutions to address the problem of identifying early indications of systemic inflammations for patients using implantable medical devices.
The present disclosure is directed toward overcoming one or more of the above-mentioned problems, though not necessarily limited to embodiments that do.
It is therefore an object of the present invention to provide an improved method and system for controlling an implantable medical device capable of identifying early indications of systemic inflammations such that immediate attention and therapy can be provided.
At least the object is solved by a computer implemented method for controlling an implantable medical device having the features of claim 1.
At least the object is furthermore solved by a system for controlling an implantable medical device having the features of claim 13.
Moreover, at least the object is solved by a computer program of claim 14 and a computer-readable data carrier having the features of claim 15.
The present invention provides a computer implemented method for controlling an implantable medical device.
The method provides the step of detecting a geographic location of the implantable medical device and/or a proximity of the implantable medical device to an object and/or a person.
Furthermore, the method provides the step of at least temporarily activating and/or deactivating at least one diagnostic function of the implantable medical device and/or at least temporarily changing a transmission frequency and/or a selection of at least one medical parameter of a patient detected by the implantable medical device if the detected geographic location of the implantable medical device and/or the proximity of the implantable medical device to the object and/or person meets a predetermined condition.
In addition, the present invention provides a system for controlling an implantable medical device.
The system comprises a patient device configured to detect a geographic location of the implantable medical device and/or a proximity of the implantable medical device to an object and/or person.
Furthermore, the system comprises the implantable medical device, wherein the patient device is further configured to at least temporarily activate and/or deactivate at least one diagnostic function of the implantable medical device and/or at least temporarily change a transmission frequency and/or a selection of at least one medical parameter of a patient detected by the implantable medical device if the detected geographic location of the implantable medical device and/or the proximity of the implantable medical device to the object and/or person meets a predetermined condition.
Instead of the Patient Device activates/deactivates diagnostics, or changes the transmission frequency and/or a selection of at least one medical parameter, another alternative or additional possibility is that a remote server activates/deactivates diagnostics the implantable medical device (via the patient device as hub) and/or starts to more frequently interrogate the defined parameters from the implantable device. This can be done by an algorithm. E.g., if a connectivity between Patient Device and server is established, interrogation would be the preferred communication. If no connection to/from the remote server can be established, the Patient Device triggers implantable medical device as described above.
Moreover, the present invention provides a computer program with program code to perform the method according to the present invention when the computer program is executed on a computer. In addition, the present invention provides a computer readable data carrier with program code of a computer program to perform the method according to the present invention when the computer program is executed on a computer.
It is an idea of the present invention to provide a situation dependent, temporary diagnostic or therapy feature to a specific patient population, which leads to an enhanced patient support while saving lifetime of an implantable medical device.
Further, it is thus possible to monitor high risk patients closely, after they have gotten in contact with infected persons or travel in high-risk areas, and to react quickly, if they show a change of parameters characteristic for certain infections or to SIRS (Systemic Inflammatory Response Syndrome) in general. Most common symptoms of SIRS are the following:
When two or more of these criteria are met with or without evidence of infection, patients may be diagnosed with “SIRS.”
Additionally or alternatively, the system and/or method according to the present invention may detect other symptoms as less body movement and/or specific posture patterns like lying down for a long time, which can mostly accompany one or more of the four indications of SIRS above.
According to an aspect of the present invention, the geographic location of the implantable medical device is detected by a patient device, in particular a handheld or wearable device, in particular preferably a smartphone, a smartwatch and/or a tablet computing device, wirelessly communicating with the implantable medical device, wherein the patient device determines the geographic location of the implantable medical device using GNSS (“Global Navigation Satellite System”) and/or mobile data.
Since the above-mentioned devices are customarily equipped with a GNSS sensor and/or can determine their current position based on mobile signals, the position of the implantable medical device can consequently be also determined using the patient device.
According to a further aspect of the present invention, if the predetermined condition is met, the patient device controls the implantable medical device, in particular by wireless communication, in particular preferably by Bluetooth low energy and/or Mics-Band communication, to at least temporarily activate and/or deactivate the at least one diagnostic function of the implantable medical device and/or to at least temporarily change the transmission frequency and/or the selection of the at least one medical parameter of a patient detected by the implantable medical device.
Thus, the battery intensive detecting of the geographic location of the implantable medical device and/or the proximity of the implantable medical device to an object and/or person as well as the detection, if the predetermined condition is met, is thus performed by the patient device, for which battery/energy usage is no issue. This in turn conserves energy of the implantable medical device.
According to a further aspect of the present invention, the predetermined condition is met if the detected geographic location of the implantable medical device is classified as a high-risk area or poses a patient specific risk, in particular dependent on a specified patient condition and/or if a proximity of the implantable medical device to a high-risk object and/or a high-risk person is detected. If one of the above-mentioned conditions is met, the implantable medical device can thus advantageously activate a diagnostic function in order to check if the medical parameters of the patient deviate from an expected range.
According to a further aspect of the present invention, geographic location data of the implantable medical device and/or proximity data of the implantable medical device to the object and/or person detected by the patient device is compared to data on high-risk areas and/or patient specific risks stored in a database hosted on the patient device, the implantable medical device and/or a remote server accessible by the patient device via a network in order to determine if the predetermined condition is met. Said data comparison advantageously enables a verification of whether or not the patient was subjected to a potential risk.
According to a further aspect of the present invention, the diagnostic function of the implantable medical device is selected by a health care provider, in particular a physician, or by an algorithm using medical data of the patient stored in the patient device, the implantable medical device and/or the remote server accessible by the patient device via the network. This way the most appropriate diagnostic function of the implantable medical device can advantageously be selected.
According to a further aspect of the present invention, the content of the database is synchronized between the remote server and the implantable medical device and/or the patient device at predetermined intervals and/or when the database is updated. The implantable medical device thus always has access to current data on high-risk areas and/or patient specific risks.
According to a further aspect of the present invention, if the predetermined condition is met, the diagnostic function of the implantable medical device is activated and/or deactivated and/or the transmission frequency and/or the selection of the at least one medical parameter of the patient detected by the implantable medical device is changed for a predetermined period of time after which the previous setting is automatically resumed or until receipt of a user generated cancellation request. The activated diagnostic function of the implantable medical device is thus run for a time period suitable to the detected risk. The cancellation request may include/cause (that) the remote server is activating/deactivating diagnostic function and/or changing the transmission frequency and/or the selection of the at least one medical parameter.
According to a further aspect of the present invention, the diagnostic function of the implantable medical device is an ECG, a temperature, impedance, respiratory function, sound, posture and/or movement measurement and/or tracking by sensors of the implantable medical device. The sound measurement can, e.g., be used to identify heart tones of the patient and to determine whether or not the measured heart tones are within an expected range. Activating diagnose function can additionally include activation of certain (self-learning) algorithms in the implant, the patient remote and/or the remote server for analyzing the correlation of the at least a subset of the above mentioned measurement, or additional values like publicly available environmental data or subjective data from the patient (e.g., via answering surveys displayed on the patient device).
According to a further aspect of the present invention, the at least one diagnostic function of the implantable medical device is activated and/or deactivated, and/or the transmission frequency and/or the selection of the at least one medical parameter of the patient detected by the implantable medical device is changed for a period of time defined by the patient and/or the health care provider, in particular a travel time period and/or a quarantine duration and/or for a time period automatically set by the implantable medical device or the patient device, in particular an incubation time. The measurement time can thus advantageously be adapted to an individual situation of the patient.
According to a further aspect of the present invention, the at least one medical parameter of the patient is surveilled for a predetermined period of time, wherein if the at least one medical parameter of the patient is outside a predefined range a message is sent from the patient device to the remote server accessible by the health care provider and/or a therapeutic function of the implantable medical device is activated. The surveillance of the measured medical parameter is thus advantageously performed at a time when needed in order to reduce a potential health risk for the patient.
According to a further aspect of the present invention, if a proximity of the implantable medical device within a predefined range, in particular within 1.5 m, to an infected person is detected, by means of proximity tracing using Bluetooth, GNSS and/or mobile data, the predetermined condition is met and/or an alert is sent from the patient device to the remote server accessible by the health care provider. Proximity tracing or in other words contact tracing can thus advantageously be used to determine whether the patient was subjected to a health risk.
The herein described features of the computer implemented method for controlling an implantable medical device are also disclosed for the system for controlling an implantable medical device and vice versa.
Additional features, aspects, objects, advantages, and possible applications of the present disclosure will become apparent from a study of the exemplary embodiments and examples described below, in combination with the Figures and the appended claims.
For a more complete understanding of the present invention and advantages thereof, reference is now made to the following description taken in conjunction with the accompanying drawings. The present invention is explained in more detail below using exemplary embodiments, which are specified in the schematic figures of the drawings, in which:
The computer implemented method for controlling an implantable medical device 10 shown in
Furthermore, the method comprises at least temporarily activating and/or deactivating S2a at least one diagnostic function 12 of the implantable medical device 10 and/or at least temporarily changing S2b a transmission frequency 14 and/or a selection 15 of at least one medical parameter MP of a patient detected by the implantable medical device 10 if the detected geographic location L of the implantable medical device 10 and/or the proximity P of the implantable medical device 10 to the object and/or person meets a predetermined condition C.
The geographic location L of the implantable medical device 10 is detected by a patient device 16, in particular a handheld or wearable device, in particular preferably a smartphone, a smartwatch and/or a tablet computing device, wirelessly communicating with the implantable medical device 10, wherein the patient device 16 determines the geographic location L of the implantable medical device 10 using GNSS and/or mobile data.
If the predetermined condition C is met, the patient device 16 controls the implantable medical device 10, in particular by wireless communication, in particular preferably by Bluetooth low energy and/or Mics-Band communication, to at least temporarily activate and/or deactivate S2a the at least one diagnostic function 12 of the implantable medical device 10 and/or to at least temporarily change S2b the transmission frequency 14 and/or the selection 15 of the at least one medical parameter MP of a patient detected by the implantable medical device 10.
The predetermined condition C is met if the detected geographic location L of the implantable medical device 10 is classified as a high-risk area or poses a patient specific risk, in particular dependent on a specified patient condition and/or if a proximity P of the implantable medical device 10 to a high-risk object and/or a high-risk person is detected.
Geographic location data D1 of the implantable medical device 10 and/or proximity data D2 of the implantable medical device 10 to the object and/or person detected by the patient device 16 is compared to data D3 on high-risk areas and/or patient specific risks stored in a database DB hosted on the patient device 16, the implantable medical device 10 and/or a remote server 18 (see
I.e., it can be determined if the current location is in an area of high risk such as a pandemic area or an area of war, or in other environments, which would create a high risk to the patient, e.g., high altitude, for which a specified close diagnosis or patient surveillance may be needed.
The database can be located remotely from the personal location device and the implant in an internal remote server like a home monitoring service center, or in an external data base, e.g., pertinent databases from organizations like governments, UN/WHO, or maps.
The diagnostic function 12 of the implantable medical device 10 is selected by a health care provider, in particular a physician, or by an algorithm using medical data 22 of the patient stored in the patient device 16, the implantable medical device 10 and/or the remote server 18 accessible by the patient device 16 via the network 20.
The content of the database DB is synchronized between the remote server 18 and the implantable medical device 10 and/or the patient device 16 at predetermined intervals and/or when the database DB is updated. The patient's health care provider may be informed about this circumstance of entering a high-risk country/area.
If the predetermined condition C is met, the diagnostic function 12 of the implantable medical device 10 is activated and/or deactivated and/or the transmission frequency 14 and/or the selection 15 of the at least one medical parameter MP of the patient detected by the implantable medical device 10 is changed for a predetermined period of time after which the previous setting is automatically resumed or until receipt of a user generated cancellation request.
The diagnostic function 12 of the implantable medical device 10 is an ECG, a temperature, impedance, respiratory function, sound and/or movement/posture measurement and/or tracking or recognition of specific signal patterns, like surveillance of behavior of SIRS parameters (Systemic Inflammatory Response Syndrome), etc. by sensors 10a of the implantable medical device 10. Activating a diagnostic or sensing feature means that functions will be activated upon determination of a/the geographic location L, which are usually not active or rarely active in the implantable medical device under normal conditions. Activating diagnose function can additionally include activation of certain (self-learning) algorithms in the implant, the patient remote and/or the remote server 18 for analyzing the correlation of the at least a subset of the above mentioned measurement, or additional values like publicly available environmental data or subjective data from the patient (e.g., via answering surveys displayed on the patient device 16).
These functions can be stored and/or pre-installed in the implantable medical device 10, or—upon determination of the geographic location L- can be selected for additional installation on the implantable medical device, either via remote programming from the remote server 18 (where the function is stored and assigned to the determined geographic location L), or from implant associated personal locating device, e.g., the patient device 16, to which the function is either downloaded on demand or pre-installed.
The selection 15 can be made by a physician or by a suitable algorithm considering all available data. In a further alternative or combination, specific therapeutic functions can be activated in the same manner, like medication or stimulation regimes, or similar.
Further, as a precautionary action, therapy proposals can be displayed on the implant associated personal location device, e.g., the administering of OTC medication or the like. Additionally, electronic surveys can be sent to the implant associated location device for retrieving subjective patient data.
The at least one diagnostic function 12 of the implantable medical device 10 is activated and/or deactivated, and/or the transmission frequency 14 and/or the selection 15 of the at least one medical parameter MP of the patient detected by the implantable medical device 10 is changed for a period of time defined by the patient and/or the health care provider, in particular a travel time period and/or a quarantine duration and/or for a time period automatically set by the implantable medical device 10 or the patient device 16, in particular an incubation time or alternatively, an unlimited or undefined period of time, which can be de-activated on health care providers discretion only.
The activated diagnostic function 12 of the implantable medical device 10 can then, e.g., be automatically or manually (by physician or patient) deactivated after return from the geographic location L.
Another additional or alternative function can be a change in the telemetry function of the device, which routinely transmits sensed or functional data from the implant directly or over several hops to an internal service center. This internal service center may be located remotely, e.g., on a remote server 18. Dependent on the analysis (e.g., by a suitable algorithm) the change can concern the frequency of these messages (e.g., several times a day, hourly, real-time) and/or the latency, the resolution and accuracy.
The patient's health care provider may be informed about activating diagnostic/sensing functions, also. An entry into patient's Electronic Health Record (EHR) can be optionally created by a suitable algorithm, thereby creating all the necessary information (survey data included).
The at least one medical parameter MP of the patient is surveilled S3 for a predetermined period of time, wherein if the at least one medical parameter MP of the patient is outside a predefined range a message is sent from the patient device 16 to the remote server 18 accessible by the health care provider and/or a therapeutic function 24 of the implantable medical device 10 is activated.
If a/the proximity P of the implantable medical device 10 within a predefined range, in particular within 1.5 m, to an infected person is detected, by means of proximity P tracing using Bluetooth, GNSS and/or mobile data, the predetermined condition C is met and/or an alert is sent S4 from the patient device 16 to the remote server 18 accessible by the health care provider.
The data derived from the activated diagnostic function 12 can be transmitted to the patient's health care provider for further consideration. This transmission can occur on a regular basis, or after reaching a certain threshold, milestone or signal pattern. The health care provider can then perform usual steps like getting in contact with the patient. Additionally, or alternatively a/the therapeutic function 24 can be started, or therapy proposals can be sent to the implant associated patient locating device, e.g., the patient device 16, or electronic prescriptions can be established for further medication therapy.
The system 1 comprises a patient device 16 configured to detect a geographic location L of the implantable medical device 10 and/or a proximity P of the implantable medical device 10 to an object and/or person.
Furthermore, the system 1 comprises the implantable medical device 10, wherein the patient device 16 is further configured to at least temporarily activate and/or deactivate at least one diagnostic function 12 of the implantable medical device 10 and/or at least temporarily change a transmission frequency 14 and/or a selection 15 of at least one medical parameter MP of a patient detected by the implantable medical device 10 if the detected geographic location L of the implantable medical device 10 and/or the proximity P of the implantable medical device 10 to the object and/or person meets a predetermined condition C.
A computer implemented method for controlling a medical device implanted into the human or animal body. The method comprises detecting S1 a geographic location L of the implantable medical device 10 and/or a proximity P of the implantable medical device 10 to an object and/or person.
Furthermore, the method comprises at least temporarily activating and/or deactivating S2a at least one diagnostic function 12 of the implantable medical device 10 and/or at least temporarily changing S2b a transmission frequency 14 and/or a selection 15 of at least one medical parameter MP of a patient detected by the implantable medical device 10 if the detected geographic location L of the implantable medical device 10 and/or the proximity P of the implantable medical device 10 to the object and/or person meets a predetermined condition C.
It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21202406.1 | Oct 2021 | EP | regional |
This application is the United States National Phase under 35 U.S.C. § 371 of PCT International Patent Application No. PCT/EP2022/074856, filed on Sep. 7, 2022, which claims the benefit of European Patent Application No. 21202406.1, filed on Oct. 13, 2021, and U.S. Provisional Patent Application No. 63/248,626, filed on Sep. 27, 2021, the disclosures of which are hereby incorporated by reference herein in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/074856 | 9/7/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63248626 | Sep 2021 | US |
