An active implantable medical device capable of distinguishing local infection from systemic infection

Abstract

The present invention relates to an active implantable medical device comprising a processor, a memory unit, a detection unit configured to detect cardiac physiological parameters, and a temperature sensor for sensing body temperature. In operation, the device performs the following steps: a) repeatedly sensing a body temperature of a person in whom the active implantable medical device is implanted with the temperature sensor, b) storing in the memory unit the body temperature values ​​obtained in step a), c) repeatedly sensing cardiac physiological parameters of the person with the detection unit, d) storing in the memory unit the cardiac physiological parameter values ​​obtained in step c), e) determining whether at least one of the body temperature values ​​exceeds a predetermined body temperature threshold, and f) if exceeding the predetermined body temperature threshold is determined, at least one of the cardiac physiological parameter values ​​exceeds a predetermined body temperature threshold. wherein at least one of the cardiac physiological parameter values ​​exceeds a cardiac physiological parameter threshold, wherein at least one of the cardiac physiological parameter values ​​exceeds the cardiac physiological parameter threshold; and g) classifying the person's infection as i) a local infection if at least one of the body temperature values ​​exceeds the body temperature threshold and at least one of the cardiac physiological parameter values ​​does not exceed the cardiac physiological parameter threshold, or ii) a systemic infection if at least one of the body temperature values ​​exceeds the body temperature threshold and at least one of the cardiac physiological parameter values ​​exceeds the cardiac physiological parameter threshold.

Description

Technical Field

[0001] The present invention relates to an active implantable medical device as described in the preamble of claim 1, an apparatus comprising such an active implantable medical device as described in the preamble of claim 9, and a computer program product as described in the preamble of claim 12.

Background Art

[0002] An increase in body temperature is an early indicator of infection, for example, an early indicator of viral infections such as influenza or COVID-19. In the case of COVID-19, available clinical data indicate that patients with heart disease appear to have a higher mortality rate compared to patients without such disease. However, an increase in body temperature can also be an indicator of local infections such as local pocket infection.

[0003] In the case of a pandemic of infectious diseases, especially in the case of a pandemic such as the COVID-19 pandemic, it is important to take necessary medical treatments and pandemic measures according to the type of detected infectious disease. If a patient is suffering only from a local pocket infection, there is no need to further examine or treat the patient at a COVID-19 center, nor can it be recommended. However, if there is a reasonable suspicion of COVID-19 infection in the case of a systemic infectious disease, it is appropriate to further examine or treat the patient at a COVID-19 center and let the patient undergo an established clinical and pandemic workflow.

[0004] Active implantable medical devices such as active cardiac implants are capable of collecting implant temperatures that directly correspond to the body temperature of the person in whom the device is implanted.

Summary of the Invention

[0005] An object of the present invention is to provide new possibilities for distinguishing between local and systemic infections in patients with an active implantable medical device in an implanted state.

[0006] This object is achieved by an active implantable medical device having the claim elements of claim 1. Such a device comprises a processor, a memory unit, a detection unit, and a temperature sensor. The detection unit serves to detect cardiac physiological parameters. The temperature sensor serves to sense body temperature.

[0007] According to one aspect of the invention according to this claim, the memory unit comprises a computer-readable program which, when executed on the processor, causes the processor to execute the steps described below.

[0008] First, the temperature sensor is made to sense the body temperature of the person in whom the active implantable medical device is implanted. In this context, the temperature sensor is made to sense the body temperature a plurality of times so that a plurality of body temperature values over time are obtained. The obtained body temperature values are stored in the memory unit.

[0009] Furthermore, the detection unit is made to sense the cardiac physiological parameters of the same person. In this context, the detection unit is made to sense the cardiac physiological parameters a plurality of times so that a plurality of cardiac physiological parameter values over time are also obtained. The obtained cardiac physiological parameters are then stored in the memory unit.

[0010] In another step, it is determined whether at least one of the body temperature values stored in the memory unit exceeds a predetermined body temperature threshold. Such an excess of the predetermined body temperature threshold is an indicator of infection. However, considering only the body temperature, it is unclear whether the infection is a local infection or a systemic infection.

[0011] Therefore, when an excess of a predetermined body temperature threshold value is determined, discrimination between systemic infection and local infection is performed. For this purpose, it is determined whether at least one of the cardiac physiological parameter values exceeds a predetermined cardiac physiological parameter threshold value. In this context, at least one of the cardiac physiological parameter values is determined in the same period as at least one of the body temperature values exceeding the body temperature threshold value. Therefore, the method performed by the active implantable medical device not only evaluates the body temperature at a specific period or a specific point in time, but also evaluates an additional parameter, i.e., the cardiac physiological parameter obtained in the same period or at the same point in time.

[0012] If at least one of the body temperature values exceeds the body temperature threshold value, but at the same time at least one of the cardiac physiological parameter values does not exceed the cardiac physiological parameter threshold value, this is regarded as an indication that the person or patient is suffering from a local infection. Therefore, the infection of that person (identified by the body temperature increase) is classified as a local infection.

[0013] However, if at least one of the body temperature values exceeds the body temperature threshold value and at the same time at least one of the cardiac physiological parameters exceeds the cardiac physiological parameter threshold value, this is regarded as an indication that the person or patient is suffering from not only a local infection but rather a systemic infection. Therefore, the infection of that person (identified by the body temperature increase) is classified as a systemic infection.

[0014] If the infection is classified as a local infection, the patient can be advised to undergo further examination and / or treatment at the hospital or medical center where the active implantable medical device was implanted. If the infection is classified as a systemic infection, the patient can be advised to contact a hospital or medical center specialized in the management and treatment of pandemic diseases. For example, such advice can be given specifically if the patient has other indicators that may indicate that the patient is suffering from a pandemic disease, such as contact with an already infected person, staying in a risk area, and / or other disease-specific symptoms.

[0015] In one embodiment, the period during which body temperature and cardiac physiological parameters are determined is a period of 6 hours to 7 days, particularly 12 hours to 6 days, particularly 18 hours to 5 days, particularly 1 day to 4 days, particularly 2 days to 3 days. The body temperature and / or cardiac physiological parameters can represent the average value of the individual body temperature values or cardiac physiological parameter values determined during such a period. Thus, the body temperature value can represent the average body temperature calculated as an average value from a plurality of (two or more, for example 2, 3, 4, 5, 6, 7, 8, 9, 10) body temperature values measured in one day or measured continuously for several days. Thus, in one embodiment, the body temperature value can represent the average body temperature for one day, for two consecutive days, or for three consecutive days. Similarly, the cardiac physiological parameter value can represent the average cardiac physiological parameter calculated as an average value from a plurality of (two or more, for example 2, 3, 4, 5, 6, 7, 8, 9, 10) cardiac physiological parameter values measured in one day or measured continuously for several days. Thus, in one embodiment, the cardiac physiological parameter value can represent the average cardiac physiological parameter value for one day, for two consecutive days, or for three consecutive days.

[0016] In one embodiment, it is necessary for at least two (or exactly two), at least three (or exactly three), at least four (or exactly four), or at least five (or exactly five) body temperature values to exceed a body temperature threshold, and / or for at least two (or exactly two), at least three (or exactly three), at least four (or exactly four), or at least five (or exactly five) cardiac physiological parameter values not to exceed a cardiac physiological parameter threshold for classifying an infection as a local infection.

[0017] In one embodiment, at least two (or exactly two), at least three (or exactly three), at least four (or exactly four), or at least five (or exactly five) body temperature values are required to exceed a body temperature threshold, and / or at least two (or exactly two), at least three (or exactly three), at least four (or exactly four), or at least five (or exactly five) cardiac physiological parameter values are required to exceed a cardiac physiological parameter threshold for classifying the infection as a systemic infection.

[0018] The term "active implantable medical device" is well known to those skilled in the art. An "active medical device" is typically defined as any medical device that depends for its function on an electrical energy source or any power source other than one directly generated by the human body or gravity.

[0019] An "active implantable medical device" is typically defined as any active medical device that is intended to be introduced, fully or partially, surgically or medically, into the human body or into a natural orifice by medical intervention and that is intended to remain after the treatment.

[0020] Further details regarding active implantable medical devices can be found, for example, in the consolidated versions of Council Directive 90 / 385 / EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as amended subsequently in the version published on 11 October 2007. The consolidated versions of this Council Directive are freely accessible at the following link: https: / / eur-lex.europa.eu / legal-content / EN / TXT / ?uri=CELEX:01990L0385-20071011.

[0021] In one embodiment, the active implantable medical device is an implantable pulse generator (IPG), an implantable cardioverter-defibrillator (ICD), a device for cardiac resynchronization therapy (CRT), a nerve stimulation device, or an implantable heart monitor. Generally, the active implantable medical device may be any implantable medical device capable of detecting a person's cardiac physiological parameters and body temperature, and is particularly equipped to perform the methods described above.

[0022] In one embodiment, the cardiac physiological parameter values are heart rate, resting heart rate, respiratory rate, resting respiratory rate, cardiac impedance, cardiac contractility, cardiac output, heart rate variability, respiratory arrhythmia, oxygen saturation, blood flow velocity, and / or heart sound. In this context, the heart rate or respiratory rate (regardless of whether measured at rest) is the mean or average rate. The mean can be calculated from multiple measurements taken on the same day. And the mean average value corresponds to the average rate per day. In one embodiment, the average value is calculated from multiple values obtained on different days. In one embodiment, the average rate is obtained from values obtained at the same time point on different days. One time point is considered the same as another time point if it does not differ from the other time point by more than 1 second to 10 minutes, particularly 10 seconds to 9 minutes, particularly 20 seconds to 8 minutes, particularly 30 seconds to 7 minutes, particularly 40 seconds to 6 minutes, particularly 50 seconds to 5 minutes, particularly 1 minute to 4 minutes, particularly 2 minutes to 3 minutes.

[0023] In one embodiment, the cardiac physiological parameter is the heart rate or the resting heart rate, particularly the average heart rate or the average resting heart rate. In this context, the cardiac physiological parameter threshold is set to be a heart rate in the range of 80 to 110 beats per minute, particularly 85 to 105 beats per minute, particularly 89 to 104 beats per minute, particularly 94 to 99 beats per minute. Next, for example, a heart rate of at least 81 beats per minute, particularly at least 90 beats per minute, particularly at least 95 beats per minute, particularly at least 100 beats per minute, particularly at least 105 beats per minute, particularly at least 111 beats per minute exceeds this threshold, and thus, when a body temperature increase is detected simultaneously, it indicates a systemic infection. In other words, a heart rate or a resting heart rate of at least 80 beats per minute, particularly at least 85 beats per minute, particularly at least 90 beats per minute, particularly at least 95 beats per minute, particularly at least 100 beats per minute, particularly at least 105 beats per minute is regarded as an indicator of systemic infection when a body temperature increase is detected simultaneously. When the heart rate is regarded as the cardiac physiological parameter, in one embodiment, the threshold is 89 beats per minute or more. When the resting heart rate is regarded as the cardiac physiological parameter, in one embodiment, the threshold is in the range of 80 to 89 beats per minute.

[0024] In one embodiment, the cardiac physiological parameter is the heart rate or the resting heart rate. Further, the computer-readable program causes the processor to determine an excess of the cardiac physiological parameter threshold when the heart rate or the resting heart rate is at least 110% of the average heart rate or the average resting heart rate, respectively, for the last several days of the first number before the determination of the excess. In this context, the first number is a number selected from the range of 3 to 400, particularly 5 to 365, particularly 10 to 350, particularly 15 to 300, particularly 20 to 250, particularly 25 to 200, particularly 30 to 190, particularly 40 to 180, particularly 50 to 150, particularly 60 to 120, particularly 70 to 100, particularly 80 to 90. across

[0025] In one embodiment, the body temperature threshold is a temperature in the range of 37.5°C to 38.5°C, particularly 37.6°C to 38.4°C, particularly 37.7°C to 38.3°C, particularly 37.8°C to 38.2°C, particularly 37.9°C to 38.1°C. For example, according to the definition by the Centers for Disease Control and Prevention (CDC), a person is considered to have a fever when they have a measured temperature of at least 38.0°C. Therefore, when the body temperature threshold is set to be 37.9°C or lower, a person with a fever according to the CDC definition will be correctly identified when applying the method performed by the active implantable medical device according to this claim.

[0026] In one embodiment, the computer-readable program causes the processor to sense the body temperature multiple times a day. For example, the body temperature can be sensed 2 to 12 times a day, particularly 3 to 11 times a day, particularly 4 to 10 times a day, particularly 5 to 9 times a day, particularly 6 to 8 times a day. In one embodiment, the body temperature can be sensed every hour, that is, 24 times a day. In one embodiment, body temperature is sensed every 30 minutes, that is, 48 times a day. In one embodiment, the body temperature is sensed at intervals from every 15 minutes to every 2 hours, particularly from every 30 minutes to every 1.5 hours, particularly from every 45 minutes to every 1 hour.

[0027] In one embodiment, the computer-readable program causes the processor to sense the body temperature for multiple days, particularly 2 to 14 days, particularly 3 to 13 days, particularly 4 to 12 days, particularly 5 to 11 days, particularly 6 to 10 days, particularly 7 to 9 days.

[0028] In one embodiment, the computer-readable program causes the processor to output an alert when the actual body temperature value exceeds the body temperature threshold and, optionally, when the cardiac physiological parameter value also exceeds the cardiac physiological parameter threshold.

[0029] Such alerts can be used as indicators of local or systemic infection in patients wearing an implanted medical device in an implanted state. Medical staff, especially physicians, who evaluate the patient's data, can inform the patient that they may be infected and take appropriate measures. Alternatively, alerts in cases where there is a suspicion of systemic infection (e.g., there may be a possibility of influenza infection or COVID-19 infection) can be automatically processed and communicated to the patient.

[0030] In one aspect, the present invention relates to an apparatus comprising an active implantable medical device, particularly an active implantable medical device as described above, and an evaluation unit. The evaluation unit is arranged separately from the active implantable medical device. The active implantable medical device comprises a first processor, a first memory unit, a detection unit, a temperature sensor, and a data communication unit. The detection unit serves to detect the cardiac physiological parameters of the patient in whom the active implantable medical device is implanted. Similarly, the temperature sensor serves to sense the body temperature of the same patient.

[0031] The first memory unit comprises a first computer-readable program that causes the first processor to execute the steps described below when executed on the processor.

[0032] First, the processor causes the temperature sensor to repeatedly sense the body temperature of the patient in whom the active implantable medical device is implanted. Thereby, a plurality of body temperature values are obtained.

[0033] Furthermore, the first processor causes the detection unit to repeatedly sense the cardiac physiological parameters of a person. Thereby, a plurality of cardiac physiological parameters of the person are obtained.

[0034] The body temperature values and the cardiac physiological parameter values are then transmitted via the data communication unit to an evaluation unit arranged outside the person's body.

[0035] The evaluation unit includes a second processor and a second memory unit. The second memory unit includes a second computer-readable program that causes the steps described below when executed on the second processor.

[0036] First, the transmitted body temperature value and the transmitted cardiac physiological parameter value are stored in the second memory unit.

[0037] Furthermore, it is determined whether at least one of the body temperature values exceeds a predetermined body temperature threshold.

[0038] If such an excess of the predetermined body temperature threshold is determined, it is further determined whether at least one of the cardiac physiological parameter values exceeds a predetermined cardiac physiological parameter threshold. In this context, at least one of the cardiac physiological parameter values is determined during the same period or at the same time as at least one of the body temperature values that exceed the threshold. temperature threshold value is determined during the same period or at the same time as at least one of the body temperature values that exceed the threshold.

[0039] If an excess of the predetermined body temperature threshold is determined, a distinction is made between systemic infection and local infection. For this purpose, it is determined whether at least one of the cardiac physiological parameter values exceeds a predetermined cardiac physiological parameter threshold. In this context, at least one of the cardiac physiological parameter values is determined during the same period as at least one of the body temperature values that exceed the threshold. Thus, the method performed by the device not only evaluates the body temperature at a specific period or specific time, but also evaluates an additional parameter, namely, the cardiac physiological parameter obtained during the same period or at the same time.

[0040] If at least one of the body temperature values exceeds the body temperature threshold, but at the same time at least one of the cardiac physiological parameter values does not exceed the cardiac physiological parameter threshold, this is regarded as an indication that the person or patient has a local infection. Thus, the person's infection is classified as a local infection.

[0041] However, if at least one of the body temperature values exceeds the body temperature threshold and, at the same time, at least one of the cardiac physiological parameter values exceeds the cardiac physiological parameter threshold, this is regarded as an indication that the person or patient not only has a local infection but rather has a systemic infection. Therefore, the person's infection is classified as a systemic infection.

[0042] Therefore, this device serves the same purpose as the above-described active implantable medical device. However, the data evaluation and further utilization of the evaluated data are not performed directly within the active implantable medical device but rather within an external evaluation unit outside. This way, the energy consumption of the active implantable medical device is less than when evaluating data within the active implantable medical device. Since the energy source of the active implantable medical device is very limited (especially in the case of small implantable medical devices), it is generally advantageous to perform the computational tasks that consume energy outside the active implantable medical device. In such a case, additional energy is required for data transmission. However, data transmission typically requires much less energy than calculations and data manipulation within the implantable medical device.

[0043] All the examples described above regarding the memory unit and / or the processor can be transferred to the first memory unit or the first processor of the described device respectively, and / or to the second memory unit or the second processor respectively.

[0044] In one embodiment, the data communication unit serves to transfer data wirelessly to the evaluation unit. All standard data transmission protocols or specifications are suitable for such wireless data communication. Examples of standard data transmission protocols or specifications are the Medical Device Radiocommunications Service (MICS), the Bluetooth (R) Low Energy (BLE) protocol, and the Zigbee (R) specification.

[0045] In one embodiment, the first computer-readable program causes the first processor to transmit body temperature values at least once a day, particularly exactly once a day, particularly 2 to 12 times a day, particularly 3 to 11 times a day, particularly 4 to 10 times a day, particularly 5 to 9 times a day, particularly 6 to 8 times a day. In one embodiment, the data is transmitted every hour, i.e., 24 times a day. In one embodiment, the data is transmitted every 30 minutes, i.e., 48 times a day. In one embodiment, the data is transmitted at intervals from every 15 minutes to every 2 hours, particularly from every 30 minutes to every 1.5 hours, particularly from every 45 minutes to every 1 hour. In one embodiment, each body temperature value is transmitted immediately after it is sensed.

[0046] In one embodiment, for an active implantable medical device that transmits data quarterly, if data is transmitted daily, the lifespan of the active implantable medical device is shortened by up to 10%, particularly 5%, particularly 1%.

[0047] In one embodiment, the evaluation unit is arranged separately from the active implantable medical device. For example, the evaluation unit can be arranged within a medical center and can be arranged to receive body temperature data and other medical data such as cardiac physiological parameter data from a plurality of active implantable medical devices. In such a case, the data communication unit of the active implantable medical device typically transfers the body temperature value to an external local data communication unit that helps for further data transmission to the evaluation unit.

[0048] In one aspect, the present invention relates to a computer program product comprising computer-readable code that, when executed on a processor, causes the processor to execute the steps described below.

[0049] In a first step, the body temperature value obtained from the temperature sensor of the active implantable medical device and the cardiac physiological parameter value obtained from the detection unit of the same active implantable medical device are stored in the memory unit of the implantable medical device or in the memory unit of an evaluation unit arranged outside the body of the person in whom the active implantable medical device is implanted.

[0050] Based on the stored body temperature values, it is determined whether at least one of the body temperature values exceeds a predetermined body temperature threshold. Such an excess of the predetermined body temperature threshold is an indicator of infection. However, considering only the body temperature, it is unclear whether the infection is a local infection or a systemic infection.

[0051] Therefore, when an excess of the predetermined body temperature threshold is determined, discrimination between systemic infection and local infection is performed. For this purpose, it is determined whether at least one of the cardiac physiological parameter values exceeds a predetermined cardiac physiological parameter threshold. In this context, at least one of the cardiac physiological parameter values is determined for the same period as at least one of the body temperature values that exceed the body temperature threshold. Therefore, the method, as to be executed by computer-readable code, not only evaluates the body temperature at a specific period or a specific point in time, but also evaluates an additional parameter, namely, the cardiac physiological parameter obtained at the same period or the same point in time.

[0052] If at least one of the body temperature values exceeds the body temperature threshold, but at the same time at least one of the cardiac physiological parameter values does not exceed the cardiac physiological parameter threshold, this is regarded as an indicator that a person or patient is suffering from a local infection. Therefore, the infection of that person is classified as a local infection.

[0053] However, if at least one of the body temperature values exceeds the body temperature threshold and at the same time at least one of the cardiac physiological parameter values exceeds the cardiac physiological parameter threshold, this is regarded as an indicator that a person or patient is not only suffering from a local infection, but rather from a systemic infection. Therefore, the infection of that person is classified as a systemic infection.

[0054] In one aspect, the present invention relates to a method for discriminating between local infection and systemic infection of a patient in whom an active implantable medical device is implanted. Therefore, this method is useful for differential diagnosis. In this context, this method includes the steps described below.

[0055] First, the body temperature of a patient implanted with an active implantable medical device is repeatedly sensed by the temperature sensor of the active implantable medical device. The active implantable medical device further comprises a processor, a memory unit, and a detection unit configured to detect cardiac physiological parameters. The body temperature is sensed multiple times so that a plurality of body temperature values over time are obtained. The obtained body temperature values are stored in the memory unit.

[0056] Furthermore, the cardiac physiological parameters of the same patient are repeatedly sensed by the detection unit. In this context, the cardiac physiological parameters are sensed multiple times so that a plurality of cardiac physiological parameter values over time are obtained. The obtained cardiac physiological parameter values are then stored in the memory unit.

[0057] In another step, it is determined whether at least one of the body temperature values stored in the memory unit exceeds a predetermined body temperature threshold. Such an exceedance of the predetermined body temperature threshold is an indicator of infection. However, considering only the body temperature, it is unclear whether the infection is a local infection or a systemic infection.

[0058] Therefore, when an exceedance of the predetermined body temperature threshold is determined, a discrimination between systemic infection and local infection is performed. For this purpose, it is determined whether at least one of the cardiac physiological parameter values exceeds a predetermined cardiac physiological parameter threshold. In this context, at least one of the cardiac physiological parameter values is determined in the same period as at least one of the body temperature values that exceed the body temperature threshold. Thus, this method not only evaluates the body temperature at a specific period or a specific point in time, but also evaluates an additional parameter, namely, the cardiac physiological parameters obtained in the same period or at the same point in time.

[0059] If at least one of the body temperature values exceeds the body temperature threshold, but at the same time, at least one of the cardiac physiological parameter values does not exceed the cardiac physiological parameter threshold, this is person considered an indicator that the patient has a local infection. Therefore, the infection of that patient is classified as a local infection.

[0060] However, if at least one of the body temperature values exceeds the body temperature threshold and, at the same time, at least one of the cardiac physiological parameter values exceeds the cardiac physiological parameter threshold, this is person considered as an indicator that the patient is suffering from not only a local infection but rather a systemic infection. Accordingly, the patient's infection is classified as a systemic infection.

[0061] In one embodiment, the method further includes a decision step of determining that the patient is to be examined and / or treated in a hospital specializing in the treatment of infectious diseases. This decision is made when the patient's infection is classified as a systemic infection. On the other hand, if the patient's infection is classified as a local infection such as a local pocket infection, it is rather decided that the patient is not to be examined and / or treated in a hospital specializing in the treatment of infectious diseases. Rather, the patient will then be further examined and / or treated in a hospital where an active implantable medical device has been implanted or a hospital that is similarly suitable for the examination and / or treatment of such local infections.

[0062] In one embodiment, the hospital is a hospital specializing in the treatment of COVID-19. In such a case, specific clinical and pandemic work flows (such as quarantine measures) can be applied to patients suspected of having a systemic infection such as a viral infection such as influenza infection or COVID-19 infection.

[0063] All embodiments of the described active implantable medical devices can be combined in any desired way and can be transferred to the described devices, the described computer program products, and the described methods, either individually or in any combination. Further, all embodiments of the described devices can be combined in any desired way and can be transferred to the active implantable medical devices, the computer program products, and the described methods, either individually or in any combination. Similarly, all embodiments of the computer program products can be combined in any desired way and can be transferred to the active implantable medical devices, the devices, and the described methods, either individually or in any combination. Finally, all embodiments of the described methods can be combined in any desired way and can be transferred to the active implantable medical devices, the devices, and the computer program products, either individually or in any combination.

[0064] Further details of aspects of the present invention are described below with reference to exemplary embodiments and the accompanying drawings.

Brief Description of the Drawings

[0065]

Figure 1A

Figure 1B

Figure 1C

Figure 1D

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Mode for Carrying Out the Invention

[0066] FIG. 1A shows the average daily body temperature of a first patient with an active implantable medical device, i.e., an implantable pulse generator. The body temperature is measured multiple times a day, and the individual body temperature values are averaged to obtain the average daily body temperature. This average daily body temperature is stored in the memory unit of the implantable pulse generator.

[0067] On several occasions in July and November, the average daily body temperature was 38°C or higher, i.e., it exceeded the body temperature threshold of 37.9°C. Since the body temperature rapidly dropped again below the aforementioned threshold, these events were not evaluated in more detail. However, the average daily body temperature value in March showed higher values of individual body temperature values exceeding the body temperature threshold of 37.9°C, suggesting an infection in the patient.

[0068] FIG. 1B shows the patient's activity. The activity in March seems to be slightly less than in the previous months, especially regarding the days in March recorded last when the body temperature exceeded the body temperature threshold, but no clear trend can be observed. However, the patient's activity does not seem to be a good indicator for distinguishing between local and systemic infections.

[0069] Considering the average heart rate per day depicted in FIG. 1C, the situation is different. It is notable that in March, the average heart rate per day increased to a value significantly exceeding 90 beats per minute (bpm). Similar average heart rates per day could be observed on 2 days in October and November, and the value in November was consistent with the increase in the patient's body temperature. However, this was only a one-day event that did not indicate a manifest infection in the patient. In contrast, in March, the average heart rate per day exceeded 90 beats per minute for 8 days.

[0070] As can be seen from FIG. 1D, similar situations can be observed when considering the average resting heart rate per day. This average resting heart rate per day exceeded 80 beats per minute for 8 days in March, but only for 1 day in the months before that. Therefore, the patient experienced both a body temperature above 38° C. and an average heart rate per day exceeding 90 bpm on the same day in March, as well as an average resting heart rate per day exceeding 80 beats per minute.

[0071] This is regarded as an indicator of systemic infection because both body temperature and further cardiac physiological parameters exceeded their respective thresholds.

[0072] FIG. 2A shows the body temperature of another patient with an active implantable medical device, that is, also equipped with an implantable pulse generator. Here too, a body temperature increase exceeding 38° C. was observed in March (FIG. 2A).

[0073] Furthermore, the patient's activity decreased with respect to the previous day (FIG. 2B).

[0074] However, the average heart rate per day did not deviate significantly from the values obtained previously (FIG. 2C). In particular, it did not exceed the threshold of 89 bpm for two consecutive days.

[0075] Furthermore, the average resting heart rate per day did not deviate significantly from the values obtained previously, and it exceeded 80 beats per minute for only 1 day (FIG. 2D).

[0076] When taking in either the body temperature value of the second patient and the average heart rate value per day or the average resting heart rate value per day of the second patient together, it was observed that there was no clear trend in the body temperature value and at least one of the additional cardiac physiological parameters. Therefore, this clearly indicates that the second patient is suffering only from a local infection so that the patient is not advised to receive further tests and / or treatment in a hospital specializing in infectious diseases such as COVID-19. Rather, the hospital or doctor who implanted the active implantable medical device should take care of the patient and treat the local (pocket) infection in the standard way required for the patient.

Claims

1. An active implantable medical device comprising a processor, a memory unit, a detection unit configured to detect cardiac physiological parameters, and a temperature sensor for sensing body temperature, When executed on the processor, the memory unit performs the following steps, namely, a) causing the temperature sensor to repeatedly sense the body temperature of the person in whom the active implantable medical device is implanted; b) storing the body temperature value obtained in step a) in the memory unit; c) causing the detection unit to repeatedly sense the cardiac physiological parameters of the person; d) storing the cardiac physiological parameter value obtained in step c) in the memory unit; e) determining whether at least one of the body temperature values exceeds a predetermined body temperature threshold; f) when it is determined that the predetermined body temperature threshold has been exceeded, determining whether at least one of the cardiac physiological parameter values exceeds a predetermined cardiac physiological parameter threshold, wherein the at least one of the cardiac physiological parameter values is determined for the same period as the at least one of the body temperature values that exceed the body temperature threshold; g) i) when at least one of the body temperature values exceeds the body temperature threshold and at least one of the cardiac physiological parameter values does not exceed the cardiac physiological parameter threshold, classifying the person's infection as a local infection, or ii) when at least one of the body temperature values exceeds the body temperature threshold and at least one of the cardiac physiological parameter values exceeds the cardiac physiological parameter threshold, classifying the person's infection as a systemic infection; h) If the infection is classified as a local infection, advising the patient to undergo further examination and / or treatment at the hospital or medical center where the active implantable medical device was implanted, or ii) if the infection is classified as a systemic infection, advising the patient to contact a hospital or medical center specialized in the management and treatment of systemic infectious diseases comprising a computer-readable program for causing the processor to execute The cardiac physiological parameter is a heart rate or a resting heart rate, and the computer-readable program causes the processor to determine that the heart rate or the resting heart rate exceeds the cardiac physiological parameter threshold when the heart rate or the resting heart rate is at least 110% of the average heart rate or the average resting heart rate over the last few days of a first number before the determination, and the first number is a number selected from the range of 3 to 400. An active implantable medical device.

2. The active implantable medical device is an implantable pulse generator, an implantable defibrillator, a cardiac resynchronization therapy device, a nerve stimulation device, or an implantable heart monitor, according to claim 1. Active implantable medical device described.

3. The cardiac physiological parameter is at least one selected from the group consisting of heart rate, resting heart rate, respiratory rate, resting respiratory rate, cardiac impedance, myocardial contractility, cardiac output, heart rate variability, respiratory arrhythmia, oxygen saturation, blood flow velocity, and heart sound. The active implantable medical device according to claim 1 or 2, characterized in that

4. The cardiac physiological parameter is a heart rate or a resting heart rate, and the cardiac physiological parameter threshold is a heart rate in the range of 80 to 110 beats per minute. The active implantable medical device according to any one of claims 1 to 3, characterized in that

5. The body temperature threshold is a temperature in the range of 37.5°C to 38.5°C. The active implantable medical device according to any one of claims 1 to 4, characterized in that

6. The active implantable medical device according to any one of claims 1 to 5, wherein the computer-readable program causes the processor to sense body temperature multiple times a day.

7. The active implantable medical device according to any one of claims 1 to 6, wherein the computer-readable program causes the processor to sense body temperature for multiple days.

8. The active implantable medical device according to any one of claims 1 to 7, wherein the computer-readable program causes the processor to output an alert when the actual body temperature value exceeds the body temperature threshold value and the cardiac physiological parameter value also exceeds the cardiac physiological parameter threshold value.

9. An apparatus comprising an active implantable medical device and an evaluation unit separated from the active implantable medical device, wherein the active implantable medical device includes a first processor, a first memory unit, a detection unit configured to detect cardiac physiological parameters, a temperature sensor for sensing body temperature, and a data communication unit. When executed on the first processor, the first memory unit performs the following steps, namely: a) repeatedly causing the temperature sensor to sense the body temperature of a person in whom the active implantable medical device is implanted; b) repeatedly causing the detection unit to sense the cardiac physiological parameters of the person; c) transmitting the body temperature value obtained in step a) and the cardiac physiological parameters obtained in step b) to the evaluation unit disposed outside the person's body via the data communication unit. The first memory unit includes a first computer-readable program that causes the first processor to execute the steps. The evaluation unit includes a second processor and a second memory unit. When executed on the second processor, the second memory unit performs the following steps, namely: d) storing, in the second memory unit, the transmitted body temperature value and the transmitted cardiac physiological parameter value; e) determining whether at least one of the body temperature values exceeds a predetermined body temperature threshold; f) when an excess of the predetermined body temperature threshold is determined, determining whether at least one of the cardiac physiological parameter values exceeds a predetermined cardiac physiological parameter threshold, wherein the at least one of the cardiac physiological parameter values is determined for the same period as the at least one of the body temperature values that exceeds the body temperature threshold; g) i) when at least one of the body temperature values exceeds the body temperature threshold and at least one of the cardiac physiological parameter values does not exceed the cardiac physiological parameter threshold, classifying the infection of the person as a local infection, or ii) when at least one of the body temperature values exceeds the body temperature threshold and at least one of the cardiac physiological parameter values exceeds the cardiac physiological parameter threshold, classifying the infection of the person as a systemic infection; h) i) when the infection is classified as a local infection, advising the patient to undergo further examination and / or treatment at the hospital or medical center where the implantable active medical device was implanted, or ii) when the infection is classified as a systemic infection, advising the patient to contact a hospital or medical center specialized in the management and treatment of systemic infections; A second computer-readable program for causing the second processor to execute the steps above, wherein the cardiac physiological parameter is a heart rate or a resting heart rate, and the computer-readable program causes the processor to determine an excess of the cardiac physiological parameter threshold when the heart rate or the resting heart rate is at least 110% of an average heart rate or an average resting heart rate over the last few days of a first number before the determination, and the first number is a number selected from the range of 3 to 400.

10. The apparatus according to claim 9, wherein the data communication unit is arranged and designed to transfer data to the evaluation unit in a wireless manner.

11. The apparatus according to claim 9 or 10, wherein the first computer-readable program causes the first processor to transmit the body temperature value and the cardiac physiological parameter value at least once a day.

12. When executed on a processor, the following steps, namely, a) storing a body temperature value obtained from a temperature sensor of an active implantable medical device and a cardiac physiological parameter value obtained from a detection unit of the same active implantable medical device in a memory unit of the implantable medical device or in a memory unit of an evaluation unit arranged outside the body of a person in whom the active implantable medical device is implanted; b) determining whether at least one of the body temperature values exceeds a predetermined body temperature threshold; c) when it is determined that the predetermined body temperature threshold has been exceeded, determining whether at least one of the cardiac physiological parameter values exceeds a predetermined cardiac physiological parameter threshold, wherein the at least one of the cardiac physiological parameter values is determined for the same period as the at least one of the body temperature values that exceeds the body temperature threshold; d) i) classifying the person's infection as a local infection if at least one of the body temperature values exceeds the body temperature threshold and at least one of the cardiac physiological parameter values does not exceed the cardiac physiological parameter threshold, or ii) classifying the person's infection as a systemic infection if at least one of the body temperature values exceeds the body temperature threshold and at least one of the cardiac physiological parameter values exceeds the cardiac physiological parameter threshold; e) i) If the infection is classified as a local infection, advising the patient to receive further examination and / or treatment at the hospital or medical center where the active implantable medical device was implanted, or ii) if the infection is classified as a systemic infection, advising the patient to contact a hospital or medical center specialized in the management and treatment of systemic infection diseases A computer program comprising computer-readable code for causing the processor to execute The cardiac physiological parameter is a heart rate or a resting heart rate, and the computer-readable program causes the processor to determine that the heart rate or the resting heart rate exceeds the cardiac physiological parameter threshold when the heart rate or the resting heart rate is at least 110% of the average heart rate or the average resting heart rate over the last few days of a first number of days prior to the determination, and the first number is a number selected from the range of 3 to 400.

13. A method for distinguishing between local and systemic infections in a patient with an active implantable medical device implanted, the method comprising a) Repeatedly sensing the body temperature of a patient with an active implantable medical device implanted using a temperature sensor of the active implantable medical device, the active implantable medical device further comprising a processor, a memory unit, and a detection unit configured to detect cardiac physiological parameters b) Storing the body temperature value obtained in step a) in the memory unit c) Repeatedly sensing the cardiac physiological parameters of the patient d) Storing the cardiac physiological parameter value obtained in step c) in the memory unit e) Determining whether at least one of the body temperature values exceeds a predetermined body temperature threshold f) When it is determined that the predetermined body temperature threshold has been exceeded, determining whether at least one of the cardiac physiological parameter values exceeds a predetermined cardiac physiological parameter threshold, wherein the at least one of the cardiac physiological parameter values is determined in the same period as the at least one of the body temperature values that exceed the body temperature threshold; g) i) When at least one of the body temperature values exceeds the body temperature threshold and at least one of the cardiac physiological parameter values does not exceed the cardiac physiological parameter threshold, classifying the patient's infection as a local infection, or ii) When at least one of the body temperature values exceeds the body temperature threshold and at least one of the cardiac physiological parameter values exceeds the cardiac physiological parameter threshold, classifying the patient's infection as a systemic infection; h) i) When the infection is classified as a local infection, advising the patient to undergo further examination and / or treatment at the hospital or medical center where the active implantable medical device was implanted, or ii) When the infection is classified as a systemic infection, advising the patient to contact a hospital or medical center specialized in the management and treatment of systemic infectious diseases; comprising wherein the cardiac physiological parameter is the heart rate or the resting heart rate, and the computer-readable program causes the processor to determine that the heart rate or the resting heart rate exceeds the cardiac physiological parameter threshold when the heart rate or the resting heart rate is at least 110% of the average heart rate or the average resting heart rate over the last few days of a first number of days prior to the determination, and the first number is a number selected from the range of 3 to 400.

14. The method further comprises, when the patient's infection is classified as a systemic infection, determining to examine and / or treat the patient at a hospital specialized in the treatment of infectious diseases, according to the method of claim 13.

15. The method according to claim 14, wherein the hospital is a hospital specialized in the treatment of COVID-19.

Images