HK1254069B - A control apparatus and method for controlling a medical system, a portable device, an arrangement, and a computer program product - Google Patents

Description

Control device and method for controlling a medical system, portable device, apparatus, and computer program product

Technical Field

The present invention relates to a control device and method, a portable device, an apparatus and a computer program product for controlling a medical system.

Background Art

This control system, apparatus, and method provides for controlling the operation of a medical system provided with a device. For example, control data is generated based on the actual or current usage of the medical device and submitted to the medical device, which then operates according to the device control data. In known medical systems, the current usage can be detected by one or more sensors. The device control data is derived from sensor signals provided by the one or more sensors by processing sensor data representing the sensor signals.

EP 2 190 503 B1 discloses a wearable infusion pump system including an activity sensor for monitoring a user's activity while the pump system is carried or otherwise worn by the user. The activity sensor detects movement characteristics of the user or physiological parameters of the user, which may indicate physical exercise, among other things. Employing such a sensor allows for detecting activity levels and adjusting the medication regimen accordingly to the user's needs.

US Pat. No. 7,879,026 B2 describes an infusion pump system that incorporates an accelerometer or other motion sensor to detect a user's activity level. If the user's activity level indicates that they are exercising or otherwise experiencing an elevated level, the infusion pump device can be configured to automatically adjust the rate at which medications such as insulin are administered. Accordingly, the insulin delivery rate can be corrected to account for the user's activity level (e.g., elevated activity levels during exercise, etc.) without having to rely on the user's instructions to change the delivery rate.

The system described in EP 1 255 578 B1 comprises a measuring device for detecting a value to be correlated with a blood glucose level, a control component comprising a controller for processing the measured values according to a control algorithm, and a hormone dosing unit for dosing hormone doses. Additionally, the degree of physical activity of the diabetic patient is taken into account by a guidance control device having an activity measuring unit for sensory detection of the degree of physical activity of the patient. With regard to the differentiated detection of the patient's resting state, such as lying, sitting, standing, the guidance control device has a position sensor, and in particular, a mercury switch or a spirit level. In order to detect the state of movement, the guidance control device has a movement sensor, such as a pedometer. For indirect detection, the guidance control device may further include sensors for detecting patient body parameters, such as heart rate, body temperature or skin conductivity.

US 8,601,005 B2 discloses a portable device that accesses a food database via the internet. The portable device detects its location using GPS coordinates. Based on the detected location, the portable device queries a food database, which returns a list of menu items for that specific location. For example, if the first food source location is a fast food restaurant, the processor uses the food database to refine the list of available food items based on that location. If the portable device is located at a second food source location, the menu of items will be based on the items available at that location. Manual entry of contextual data/health events (illness, physical activity, etc.) for automatically recommending single dose adjustments/corrections (after confirmation of use) already exists (e.g., EP 2 627 251 B1).

Summary of the Invention

The object is to provide an improved technique for controlling a medical system provided with a medical device to be operated. In particular, the operation of the medical system depending on different use scenarios should be improved.

According to the present disclosure, a control device and a method for controlling a medical system are provided according to claims 1 and 12, respectively. Claim 9 relates to a portable device. Furthermore, an apparatus comprising a medical device and a control device is provided according to claim 10. Furthermore, a computer program product is provided according to claim 15. Further developments are disclosed in the dependent claims.

According to one aspect, a control apparatus for providing control data in a medical system is provided. The control apparatus includes a portable device and a plurality of context data carriers. The context data carriers include a first context data carrier placed in a first location within a usage environment of the portable device. Furthermore, the control apparatus includes a data processing system provided in the portable device, the data processing system having a data input interface and a device controller functionally connected to the data input interface. The data processing system is configured to receive first local context data from the first context data carrier via the data input interface, the first local context data indicating at least one of location, patient identity, patient activity, and time. The data processing system is further configured to generate context-dependent device control data by the device controller in response to receiving the first local context data, including processing or analyzing the first local context data and generating the first context-dependent device control data based on electronic context information derived from the processing of the first local context data. Furthermore, the data processing system is configured to output output data indicating the first context-dependent device control data via a data output interface of the portable device.

According to another aspect, a portable device is provided. The portable device comprises a data handling system provided with a data input interface and a device controller functionally connected to the data input interface. The data handling system is configured to: receive first local context data from a first context data carrier via the data input interface; generate context-dependent device control data by the device controller in response to receiving the first local context data, including analyzing the first local context data and generating the first context-dependent device control data in dependence on context information derived from the analysis of the first local context data; and output output data indicating the first context-dependent device control data via a data output interface of the portable device.

According to yet another aspect, an apparatus is provided, comprising a medical device and a control device. The medical device is functionally connectable to the control device for receiving context-dependent device control data from the control device. The apparatus comprising the medical device and the control system can be provided as a portable system, for example, a portable system to be worn on the body. Alternatively, the medical system can be a non-portable medical system combined with the control system comprising the portable device.

According to another aspect, a method for controlling a medical system is provided. The method includes providing a control device, the control device including: a portable device; a plurality of context data carriers, each of which has a first context data carrier individually placed in a first location in a usage environment of the portable device; and a data handling system provided in the portable device and including a data input interface and a device controller functionally connected to the data input interface. First local context data is received from the first context data carrier via the data input interface. In response to receiving the first local context data, context-dependent device control data is generated by the device controller, including analyzing the first local context data and generating the first context-dependent device control data based on context information derived from the analysis of the first local context data. Output data indicating the first context-dependent device control data is output via a data output interface of the portable device.

In addition, a computer program product for controlling a medical system by a control device is provided, the control device comprising: a portable device; a plurality of context data carriers provided with the context data carriers being placed in a first position in a usage environment of the portable device; and a data handling system provided in the portable device and comprising a data input interface and a device controller functionally connected to the data input interface, the computer program product comprising components recorded on an electronic data carrier for executing a method for controlling a medical system.

The local context data may be provided with encrypted local context data on the context data carrier.

The local context data may indicate at least one of location, patient identity, patient activity, and time. The location data may indicate the location where the context data carrier is placed. The patient activity data may indicate the level of physical activity. For example, a patient's activity level may differ for someone working in an office on one side and exercising in a gym on the other. With respect to time, the context data may refer to different control data depending on the time of day.

As used herein, the term (local) context data refers to data indicating at least one of location, patient identity, patient activity, and time. Context data can, for example, be provided by textual information. The term context-dependent control data, also referred to as contextualized or contextual (control) data, as used herein, refers to control data, such as control signal values, that are assigned to or depend on a particular context indicated by the context data. Context-dependent control data can be contained within the context data itself or derived directly from the context data itself. For example, textual information (context data) can assign signal values (context-dependent control data) received from a local context data carrier to such a context data carrier by providing a data carrier identification (e.g., an alphanumeric code such as "DC 1").

As an alternative to or in addition to including context-dependent control data in the local context data, the local context data can refer to data assignments between context data and control data, e.g., a lookup table providing assignments between local context data and (context-dependent) control data. Different context data can refer to or point to different context-dependent control data. For example, context data indicating different locations can refer to different context-dependent control data (e.g., first and second bolus doses, where the second bolus dose is different from the first bolus dose).

The context-dependent control data can be configured to control data output, such as outputting video and/or acoustic information via a display and a speaker, respectively. Alternatively or additionally, the context-dependent control data can be configured to control the operation of a functional element of a medical device provided in the medical system, such as an insulin pump or a sensor device. In this case, outputting the output data via a data output interface of the portable device further comprises transmitting the context-dependent control data to the medical device. In an embodiment, the operation of a glucose sensor can be controlled by the context-dependent control data. Medication can be dispensed via the functional element of the medical device.

The context-related control data is generated in the portable device in response to receiving context data for at least one of the context data carriers. The generation may be initiated and performed without requesting or responding to any (additional) user input.

The data handling system can further be configured to receive the local context data by at least one of: reading the local context data from a passive local context data carrier by a contactless data reader of the portable device; and receiving the local context data transmitted by a transmitter of an active context data carrier by a receiver of the portable device. The term active storage element as used herein refers to a data storage element provided with a transmitter for transmitting data. In contrast, with respect to the transmitter, a passive data storage element is inactive. The data reader can, for example, comprise a scanner and/or an RFID reader configured to scan a data matrix. The means of transmitter can be provided by a plurality of active context data carriers. For example, the active context data carrier can be provided by beacon technology (e.g. based on Bluetooth technology).

The passive local context data carrier may include at least one of a data matrix, such as a one-dimensional barcode and/or a two-dimensional barcode, and an electronic data storage element, such as an RFID transponder. The electronic data storage element is readable by a contactless reader for downloading the local context data to the portable device, but lacks a data transmitter. The data matrix may be printed on a supporting element (e.g., a label, tag, or sign). Data transmission between the transmitter device and the data handling system may be configured for contactless data communication within a local communication range. The local communication range may be limited to contactless data communication within a distance of no more than approximately 10 meters. Alternatively, the local communication range may be limited to contactless data communication within a distance of no more than approximately 5 meters, and in yet another alternative, to a distance of no more than approximately 1 meter. The transmitter may be provided in a transceiver. The transceiver implements a transmitter and a receiver configured to transmit and receive data, respectively. The device may be provided as a transceiver device.

For at least one of the active context data carrier and the passive context data carrier, the local context data may be provided when the data carrier is placed in a usage environment. The local context data may be provided with persistent local context data. With respect to electronic data stored in the data storage element, the persistent data may be provided by electronic data that cannot be overwritten.

The active context data carrier and/or the passive context data carrier may not have any sensor device and may also not be connected to a sensor device.

The transmitter of the context data carrier and the receiver of the portable device may be configured for contactless data transmission by a transmission technology selected from the group consisting of: near field data communication; and Bluetooth communication.

The portable device may include a detection module functionally connected to the device controller, and the data handling system may be further configured to detect local proximity of the portable device to the first context data carrier. In response to detecting the local proximity of the portable device to the at least one context data carrier, the controller device may generate a detection signal. Subsequently, the local context data may be received in the portable device.

The first context-related device control data may be configured to control at least one operational process of the medical device selected from the following group of operational processes: output of video data; output of audio data; output of a warning signal; control of pump operation; and modification of at least one of a medication plan, a bolus dose, a target range for a measurement such as a glucose value, a device setting of a medical device such as an insulin pump or a glucose measuring device, a threshold for a measurement such as a glucose value, an insulin profile, and a time block defining a time period. The time block may define a time period for the validity of one or more of the other data, such as the medication plan, the bolus dose, the target range for a measurement such as a glucose value, a device setting of a medical device such as an insulin pump or a glucose measuring device, a threshold for a measurement such as a glucose value, and/or an insulin profile.

The portable device may be selected from the following group of portable devices: a mobile phone; a tablet computer; a laptop computer; a portable medical device; a portable medical measurement device; and a smart watch.

The plurality of context data carriers may include a second context data carrier placed in a second location of the usage environment of the portable device different from the first location, the second local context data carrier providing second context data different from the first local context data.

With respect to the active context data carrier, the detection of the local proximity of the portable device to at least one transmitter may include unidirectional data transmission and/or bidirectional data transmission between the at least one transmitter and the portable device. In an alternative embodiment, the detection module detects the local proximity to the at least one transmitter by receiving input data only from the at least one transmitter. Such receipt of input data indicates local proximity to the at least one transmitter. With respect to such an embodiment, the data transmission is achieved by the transmitter actively transmitting data and the receiver receiving such data.

The transmitter arrangement may provide a local position reference system. The local reference system may be configured to determine the local position of the portable device when the portable device is in local proximity to at least one transmitter of the transmitter arrangement. Determining the local position of the portable device may comprise determining position data indicating the position of the portable device within the local reference system. As an alternative, determining the local position of the portable device may comprise determining the presence of the portable device within the local reference system without determining actual position data. For example, it may be merely determined that the portable device is in the vicinity of one or more transmitters. Determining the local position of the portable device may be performed by a data handling system provided in the portable device.

The emission zones defined by the individual coverage areas of the emitters of the emitter arrangement may partially overlap. There may be a three-dimensional coverage area that is completely covered by the emitter arrangement. Alternatively, the emitter arrangement may provide a set of separate individual localized emitter zones, such localized zones being defined by the individual coverage areas of the locally placed emitters.

The portable device and the medical device may be provided as separate devices or, as an alternative, may be provided as a single system. Both devices may be provided in a single housing or in a plurality of connected sub-housings. If the portable device and the medical device are provided as a combined device, such a combined device may be provided as a single portable device. The components of the combined device may be disconnectable.

A control device in the medical device, which may be provided with a processor and a data storage device, may be connected to one or more functional components of the medical device and may be configured to generate control signals for a single functional component or multiple functional components (such as a data interface and/or output device for outputting video and/or audio signals). For example, the control device may be configured to control the operation of a sensor device and/or a pump device provided in the medical device.

Various aspects of the present disclosure are applicable to different configurations of medical systems. For example, a medical system may include a controller and an insulin delivery system (such as a durable product or patch pump) or a controller and a glucose monitor (such as a BG meter or continuous glucose monitoring sensor). The controller may be provided in the portable device. As another example, the technology may also be applied to an integrated or closed-loop system including an insulin delivery and monitoring device.

In an embodiment, a set comprising a portable device and a plurality of emitters may be provided as an article. Such an article would give the user the opportunity to individually create a local arrangement of emitters that is adjustable for different user situations through user-defined placement of the emitters.

A local reference grid of emitters may be provided by the emitter arrangement.A fixed reference system may be provided provided by emitters in fixed positions.

The data transmission between the transmitter device and the data processing device can be configured for contactless data communication within a local communication range. Near Field Communication (NFC) can be used for data transmission. Components of the control system can be restricted to local data communication only. Alternatively, RFID technology can be used for data exchange. Furthermore, as an alternative or in addition, beacon technology can be provided, for example using a Bluetooth transmitter. In another alternative, data exchange with WLAN (Wireless Local Area Network) equipment can be used to determine the local position of the portable device. For example, a method based on a process known as triangulation can be applied.

The portable device can be selected from the following group of portable devices: a mobile phone; a tablet computer; a laptop computer; a portable medical device, a portable medical measuring device; and a smartwatch. The portable device can be configured with a software program downloaded from the Internet, for example in the form of a so-called App. Moreover, remote control by the portable device can be provided by a pre-installed/updated program, wherein the remote control can be configured to communicate only with components of the medical device. With respect to the apparatus comprising a medical device and a control device and the method for controlling a medical system, the features outlined above can also apply. In the apparatus, the medical device can be selected from the following group of medical devices: a blood glucose meter; an insulin pump; a continuous glucose monitoring system; and an insulin pen.

With respect to the arrangement, the medical device may be placed within a local reference system provided by the transmitter arrangement.

Regarding the method, the step of providing the control system may include: loading a software application into a memory of the portable device; and running the software application on the portable device. The software application may be downloaded, for example, via the internet. One or more web applications may be part of the implementation and/or running of the software application.

The method for controlling a medical system may further comprise placing the at least one transmitter in a user-defined location in a local usage environment of the portable device. The position of one or more transmitters may be changed (repositioned) to change the transmitter arrangement to another user-defined configuration.

In the following, alternative aspects are disclosed. According to an alternative scheme, a control system for controlling a medical system is provided. The control system includes a portable device and a transmitter device. The transmitter device is provided with at least one transmitter that is individually placed in a location in the local use environment of the portable device. In addition, the control system includes a data handling system provided in the portable device, the data handling system including a detection module, a data interface, and a device controller functionally connected to the detection module and the data interface. The data handling system, which may also be referred to as a data processing system, is configured to: detect the local proximity of the portable device to the at least one transmitter by the detection module; receive input data from the at least one transmitter via the data interface; generate device control data for the medical device by the device controller, including processing the input data; and transmit the device control data to a control device of the medical device.

A portable device may be provided. The portable device includes a data processing system provided with a detection module, a data interface, and a device controller functionally connected to the detection module and the data interface, wherein the data processing system is configured to: detect, by the detection module, the local proximity of the portable device to at least one transmitter; receive input data from the at least one transmitter via the data interface; generate, by the device controller, device control data for a medical device, including processing the input data; and transmit the device control data to a control device of the medical device. The portable device is configured to be used with the control system.

An apparatus may be provided, comprising a medical device and a control system, wherein the medical device is functionally connectable to the control system for receiving device control data from the control system. The apparatus comprising the medical device and the control system may be provided as a portable system, for example, a portable system to be worn on the body. Alternatively, the medical system may be a non-portable medical system combined with the control system comprising the portable device.

As an alternative, a method for controlling a medical system may be provided. The method comprises providing a control system comprising a portable device, a transmitter device, and a data processing system, wherein the transmitter device is provided with at least one transmitter that is individually placed in a location in a local use environment of the portable device, and the data processing system is provided in the portable device and comprises a detection module, a data interface, and a device controller functionally connected to the detection module and the data interface. The detection module detects the local proximity of the portable device to the at least one transmitter. In addition, the data processing system receives input data from the at least one transmitter via the data interface. The device controller generates device control data for the medical device, including processing the input data. The device control data is transmitted to the medical device via the data interface, and the medical device is controlled or operated according to the device control data.

In addition, a computer program product for controlling a medical system by a control system can be provided, the control system comprising a portable device, a transmitter device and a data processing system, the transmitter device being provided with at least one transmitter individually placed in a location in a local use environment of the portable device, the data processing system being provided in the portable device and comprising a detection module, a data interface, and a device controller functionally connected to the detection module and the data interface, the computer program product comprising components recorded on an electronic data carrier for executing a method for controlling a medical system.

Detection of the localized proximity of the portable device to the at least one transmitter may include unidirectional data transmission and/or bidirectional data transmission between the at least one transmitter and the portable device. In an alternative embodiment, the detection module detects the localized proximity to the at least one transmitter by receiving input data only from the at least one transmitter. Such receipt of input data indicates the localized proximity to the at least one transmitter.

The transmitter arrangement may provide a local position reference system. The local reference system may be configured to determine the local position of the portable device when the portable device is in local proximity to at least one transmitter of the transmitter arrangement. Determining the local position of the portable device may comprise determining position data indicating the position of the portable device within the local reference system. As an alternative, determining the local position of the portable device may comprise determining the presence of the portable device within the local reference system without determining actual position data. For example, it may be merely determined that the portable device is in the vicinity of one or more transmitters. Determining the local position of the portable device may be performed by a data handling system provided in the portable device.

The emission zones defined by the individual coverage areas of the emitters of the emitter arrangement may partially overlap. There may be a three-dimensional coverage area that is completely covered by the emitter arrangement. Alternatively, the emitter arrangement may provide a set of separate individual localized emitter zones, such localized zones being defined by the individual coverage areas of the locally placed emitters.

The portable device and the medical device may be provided as separate devices or, as an alternative, may be provided as a single system. Both devices may be provided in a single housing or in a plurality of connected sub-housings. If the portable device and the medical device are provided as a combined device, such a combined device may be provided as a single portable device. The components of the combined device may be disconnectable.

A control device in the medical device, which may be provided with a processor and a data storage device, may be connected to one or more functional components of the medical device and may be configured to generate control signals for a single functional component or multiple functional components (such as a data interface and/or output device for outputting video and/or audio signals). For example, the control device may be configured to control the operation of a sensor device and/or a pump device provided in the medical device.

Various aspects of the present disclosure are applicable to different configurations of medical systems. For example, a medical system may include a controller and an insulin delivery system (such as a durable product or patch pump) or a controller and a glucose monitor (such as a BG meter or continuous glucose monitoring sensor). The controller may be provided in the portable device. As another example, the technology may also be applied to an integrated or closed-loop system including an insulin delivery and monitoring device.

As an article, a set comprising a portable device and a plurality of emitters may be provided. Such an article would give the user the opportunity to individually create a local arrangement of emitters that is adjustable to different user situations through user-defined placement of the emitters.

A local reference grid of transmitters may be provided by the transmitter arrangement. When the local proximity is detected by the detection module and the input data is received via the data interface, the at least one transmitter may be in a fixed local position at least at the time of data exchange. A fixed reference system provided by the transmitters in fixed positions may be provided.

As an alternative, data transmission between the transmitter device and the data processing device can be configured for contactless data communication within a local communication range. Near-field communication (NFC) can be used for data transmission. Components of the control system can be restricted to local data communication only. As an alternative, RFID technology can be used for data exchange. Furthermore, as an alternative or in addition, beacon technology can be provided, for example using a Bluetooth transmitter. In another alternative, data exchange with WLAN (wireless local area network) equipment can be used to determine the local position of the portable device. For example, a method based on a process known as triangulation can be applied.

The local communication range may be limited to contactless data communication within a distance of no more than about 10m. Alternatively, the local communication range may be limited to contactless data communication within a distance of no more than about 5m, and in another alternative, limited to a distance of no more than about 1m. The at least one transmitter may be provided in a transceiver. The transceiver implements a transmitter and a receiver configured to transmit and receive data, respectively. The device may be provided as a transceiver device.

The device control data may be configured to control at least one operational process of the medical device selected from the following group of operational processes: video data output; audio data output; outputting a warning signal; controlling pump operation; modifying a medical therapy plan; and modifying a medication plan.

The portable device may be selected from the following group of portable devices: a mobile phone; a tablet computer; a laptop computer; a portable medical device; a portable medical measurement device; and a smartwatch. The portable device may be configured with a software program, such as an app, downloaded from the internet. Furthermore, remote control by the portable device may be provided by a pre-installed/updated program, wherein the remote control may be configured to communicate only with components of the medical device.

At least one of the input data and the device control data may include contextualization data. As used herein, the term contextualization data may refer to a combination of a single value and textual information. For example, with respect to input data, the textual information may assign a signal value received from a transmitter to such transmitter by providing a transmitter identifier (e.g., an alphanumeric code such as "TR 1"). With respect to the device control data, the textual information added to a control signal value may indicate a functional element to be controlled by the control signal value.

Input data and/or device control data, including or excluding contextualization data, can be processed by a control device of the medical device during medical data processing within the medical device. Medical data processing within the medical device can include processing the input data and/or the device control data. For example, the frequency with which medical data processing within the medical device (e.g., determining a blood glucose level based on measurement data) is performed can depend on the input data and/or the device control data.

The features outlined above also apply to an apparatus comprising a medical device and a control system, and a method for controlling a medical system. In the apparatus, the medical device may be selected from the following group of medical devices: a blood glucose meter; an insulin pump; a continuous glucose monitoring system; and an insulin pen. In the apparatus, the medical device may be placed within a local reference system provided by the transmitter device.

Regarding the method, the step of providing the control system may include: loading a software application into a memory of the portable device; and running the software application on the portable device. The software application may be downloaded, for example, via the internet. One or more web applications may be part of the implementation and/or running of the software application.

BRIEF DESCRIPTION OF THE DRAWINGS

Hereinafter, an embodiment as an example is described with reference to the accompanying drawings. In the accompanying drawings:

FIG1 is a schematic representation of a control system for controlling a medical system;

FIG2 is a schematic representation of a portable device; and

FIG3 is a schematic representation of an alternative control system for controlling a medical system.

DETAILED DESCRIPTION

FIG1 shows a schematic representation of a control system or apparatus for controlling a medical system. An apparatus 1 is provided, comprising a plurality of active context data carriers 1.1, ..., 1.n, each of which is locally provided with a data transmitter. The active context data carriers 1.1, ..., 1.n cover a local area 2, thereby providing a fixed local reference system. A portable device 3 is provided, such as a mobile phone or tablet computer. The covered area 2 provides an area for use of the portable device 3.

As shown in FIG1 , a portable device 3 is located near one of the active context data carriers 1.1, ..., 1.n. This proximity is detected by the portable device 3. In response to detecting the proximity to one of the active context data carriers, context-related device control data is generated in the portable device 3 and transmitted to the medical device 4. The medical device 4 may be, for example, a blood glucose meter or an insulin pump. In response to receiving the context-related device control data from the portable device 3, the medical device 4 is operated according to the context-related device control data.

As an alternative, the context-related control data generated in the portable device may provide for controlling data output by the portable device, eg outputting video and/or audio data via a display of the portable device 3, a speaker of the portable device 3, respectively.

With respect to FIG. 1 , the apparatus may be provided as a transmitter apparatus. The active context data carriers 1.1, ..., 1.n may be provided as a plurality of transmitters. The transmitter arrangement may cover a local area 2, thereby providing a fixed local reference system. With respect to this alternative, as shown in FIG. 1 , a portable device 3 is located near one of the transmitters from the plurality of transmitters. This proximity may be detected by the portable device 3. In response to detecting proximity to one of the transmitters, device control data is generated in the portable device 3 and transmitted to the medical device 4. The medical device 4 may be, for example, a blood glucose meter or an insulin pump. In response to receiving the device control data from the portable device 3, the medical device 4 is operated according to the device control data.

1 , there is a central server device 5 that can be connected to the portable device 3 and/or the medical device 4 for data transmission, for example, via the Internet. In an embodiment, the remote control function provided by the portable device 3 can be implemented on the portable device 3 by downloading a software application from the central server device 5 and running the software application on the portable device 3.

FIG2 shows a schematic representation of a portable device 3 in more detail. To provide remote control of a medical device 4 in response to the portable device 3 being positioned within an apparatus 1 where active context data carriers 1.1, ..., 1.n can be provided by a transmitter, the portable device 3 is provided with a detection module 6, a data input interface 7 (or data interface), and a device controller 8 functionally connected to the detection module 6 and the data input interface 7. A data output interface 9 functionally connected to the device controller 8 is provided for outputting data. The detection module 6 receives local context data from at least one of the active context data carriers 1.1, ..., 1.n when the portable device 3 is brought into local proximity with the respective active context data carrier within the local area 2.

In response to receiving input data, such as local context data, from one or more of the active context data carriers 1.1, ..., 1.n, device control data or context-dependent device control data for the medical device 4 is generated by the device controller 8. In this process of generating the context-dependent device control data, the local context data is processed in the portable device 3. Control data, such as the generated context-dependent device control data, is transmitted to a control device of the medical device 4. Subsequently, the operation of the medical device 4 is controlled based on the context-dependent device control data received from the portable device 3. The received control data may control any function of the medical device 4. One or more operational functions may be controlled by the device control data.

In an alternative embodiment, context-related control data generated in the portable device 3 in response to receiving the context data may be provided for controlling the data output of the portable device 3 itself. Such data output control may be provided as an alternative to or in addition to providing the context-related control data to the medical device 4.

FIG3 shows a schematic representation of an alternative control system for controlling a medical system. A plurality of passive context data carriers 30.1, ..., 30.n are located at different locations in the environment in which the portable device 3 is used. In contrast to the active context data carriers 1.1, ..., 1.n, the passive context data carriers 30.1, ..., 30.n do not have a data transmitter. Rather, the context data provided by the respective passive context data carrier can (only) be read from the data carrier using one or more techniques, but this context data is not actively transmitted from the data carrier by a data transmitter. For example, one of the passive context data carriers 30.1, ..., 30.n could be located in the car of a patient who owns the portable device 3. Another of the passive context data carriers 30.1, ..., 30.n could be located in the patient's apartment or on their bicycle.

In an alternative embodiment, the usage environment of the portable device 3 may be provided with a combined arrangement of context data carriers comprising at least one active context data carrier and at least one passive context data carrier.

At least some of the passive context data carriers 30.1, ..., 30.n provide different context data that can be read by the portable device 3 (e.g., by a scanner or contactless reader provided with the portable device 3). With respect to the embodiment shown in FIG3 , the portable device 3 does not necessarily need to include a detection module 6. Context-related control data are generated in the portable device 3 in response to receiving local context data from at least one of the passive context data carriers 30.1, ..., 30.n.

The passive context data carriers 30 . 1 , . . . , 30 . n can “carry” or provide local context data by means of a data matrix such as a one-dimensional or two-dimensional barcode and/or an electronic data storage element.

Context-dependent control data may be included directly in the local context data. In this case, contextualization or context control data may be provided directly by the passive context data carriers 30.1, ..., 30.n. Similarly, active context data carriers 1.1, ..., 1.n may provide contextualization or context data.

Alternatively or additionally, the local context data provided by the passive context data carriers 30.1, ..., 30.n or the active context data carriers 1.1, ..., 1.n may refer to data assignments, for example, a lookup table providing assignments between local context data and context-related control data. Different context data may refer to or point to different context-related control data. For example, context data indicating different locations may refer to different context-related control data (e.g., first and second bolus doses, the second bolus dose being different from the first bolus dose).

Today, people with diabetes must manually adjust their therapy settings each time, depending on factors such as location, time of day, and activity. Therefore, there's always the possibility of selecting the wrong value. For example, an insulin pump/patch pump/CGM or another diabetes device (smartphone, smartwatch) used as a medical device by people with diabetes could work with a control system or device to enable and provide new opportunities in therapy.

The location data can be used to notify the user/patient about taking sugary foods with them when leaving the house. A transmitter or contextual data carrier device provides a local reference or usage system located in the user/patient's house. A contextual data carrier, such as a transmitter, can be located near a door (a "door or entrance transmitter"). When a portable device comes into proximity with such a transmitter, the location information provided by the contextual data carrier or transmitter is processed and context-related control data, such as recommendations, is output. Alternatively or additionally, the therapy plan implemented and/or output to the user/patient can be modified in response to receiving local contextual data from the door transmitter.

Alternative examples may include active or passive contextual data carriers (e.g., transmitters) placed in a car (location data = car), and context or contextual data ranges serving as warning limits (e.g., regarding glucose levels) can be adjusted to match what is considered safe for driving. Alternative scenarios include contextual data carriers (e.g., transmitters on a user's sports equipment) that indicate higher activity levels and can trigger a lower basal infusion rate. Sensors could, for example, be attached to both sneakers and a shirt. Identifying both in close proximity allows for additional authenticity checks. Furthermore, via the contextual data carrier, therapy data can be made accessible to others based on location data and/or contextual data (such as activity level). Adjustments can further include safety checks via additional data from the controller (GPS—Global Positioning System, date, time), activity sensors, and so on. Detecting proximity to the transmitter(s) in the car can be used to adjust appropriate diabetes value limits (bG > 120 mg/dl or 6.7 mmol/l) during driving. Similarly, one or more passive contextual data carriers can be provided in the car. If the diabetic exceeds the safe driving range, a notification will appear. Additionally, blood sugar levels should be checked every two hours. Therefore, time is used to start a timer at the beginning of driving. After two hours, the diabetic is notified to check his/her blood sugar. If the diabetic stops driving, the value will be set to the default value and the timer will stop.

In another alternative, if the system provides the ability to configure different basal infusion rate profiles (e.g., once for weekdays and once for weekends), location information (contextual data) indicating the presence of the portable device (and medical device) at home or at work can be used to automatically activate the appropriate profile based on the day of the week. Separate contextual data carrier devices or transmitter devices at home and at work would be used to locate the location of the portable device.

Location information provided with contextual data regarding the user's or patient's physical activity can be used to automatically adjust warning limits for blood glucose levels. Warning limits to be set or reset in the portable device 3 by context-dependent control data can be derived from directly read context data or from a lookup table pointed to by the context data. If a diabetic patient's blood glucose level is getting low, the patient will be notified and advised to take an appropriate amount of carbohydrates to continue exercising. Additionally, if the system provides the ability to configure different basal infusion rate profiles (e.g., for sports), the profiles can be automatically activated by the context-dependent control data at the adjusted basal infusion rate. For example, a context data carrier, such as a transmitter, can be provided on the bicycle and/or in a location where storage for the bicycle is provided.

As an example, active context data carriers 1.1, ..., 1.n or transmitters can be provided by beacons. Configurable Bluetooth beacons (see iBeacon) can be used as context data carriers: they are configured to activate different types of settings via context-dependent control data (medical device control). As an example, a Bluetooth beacon can be attached to a sports bag. If a diabetic patient is about to exercise, the beacon's signal can be used to activate a predefined sports basal infusion profile for the diabetic patient. Another possibility is to use Bluetooth beacons in restaurants, where the appropriate amount of carbohydrates can be provided via transmitters attached to plates or dishes.

The location data that can be provided by the local context data can be used to provide context-relevant control data instructions in the local language of the residents of the visited country, such as "Help, I'm a diabetic!" or "Where is the next pharmacy?" or "Call an ambulance!" For this purpose, one or more context data carriers that can be provided with a transmitter can be located at the customer kiosk.

In an alternative arrangement, contextual data carriers such as transmitters can form a fixed reference system or grid, within which medical devices such as pumps/blood glucose sensors/controller systems move. The portable device 3 can detect an individually placed transmitter when it comes into close proximity with one of the transmitters. Based on the proximity to the transmitter and the received contextual data, the system can provide insights into the user's condition and adjust therapy accordingly. Such therapy adjustments can include, for example, changes to the basal infusion rate, warnings (alarm settings or blood glucose warning limits), or bolus doses.

Different aspects of the disclosed technology are applicable to different configurations of medical systems. For example, a system can include a controller and an insulin delivery system (medical device) (such as a durable or patch pump) or a controller and a glucose monitor (such as a BG meter or continuous glucose monitoring sensor). It can also be applied to integrated or closed-loop systems that include both insulin delivery and monitoring devices.

When the medical system and in particular the controller (portable device) moves in a fixed reference system of a context data carrier such as a transmitter, the therapy adjustment depends on the position transmitted to the controller and the context information linked to this positioning data.

Active contextual data carriers or transmitters can be distributed in different locations in an individualized manner depending on the patient's habits. The contextual data can be provided directly by the transmitter (e.g., information stored on a contextual data carrier (e.g., a transmitter) attached to a plate in a restaurant with carbohydrate-related information), via a lookup table stored on a controller for matching locations with contextual data, or on a remote database accessible via a network.

Below, further aspects are provided regarding passive contextual data carriers. Reference is made to embodiments in the field of diabetes management. A barcode provided on the contextual data carrier can be used to change user settings related to the user's diabetes management. The barcode can contain an indicator (ID) for a specific preset profile or data for creating new settings. Two types of barcodes can be used: one-dimensional and two-dimensional.

Regarding context-dependent control data, different uses can be provided for both types: identifying preset settings and creating new settings. Individual settings that can be identified or, more precisely, created can refer to at least one of the following: an insulin profile; a target range for BG values at a specific time; and thresholds (upper and lower limits) for BG values at a specific time.

For context-dependent settings, a time block may be assigned. A time block as referred to herein is a time span having a start time and an end time indicating the above-listed therapy settings with corresponding values.

In the case of a one-dimensional barcode, the barcode can be defined using the EAN-13 standard, which is a 13-digit barcode in which one digit is a checksum. The number of digits that can be used is 12. In an alternative embodiment, the first two digits indicate what is to be set or created: 00 - insulin profile; 01 - meal bolus; 02 - target range for BG values at a specific time; and 03 - thresholds (upper and lower limits) for BG values at a specific time.

The next four digits can indicate the time span in which the setting is valid or an instruction for loading a preset data record. If these four digits are 9999, they indicate a preset record. If the digits are 9898, they indicate a non-time-related change. Otherwise, the digits indicate the start and end time, each using two digits and a resolution of 15 minutes. These two digits begin with 00, which represents 00:00 hours. From this point on, they increment by one, representing the actual time plus 15 minutes (for example, 01 represents 00:15 hours, and 6 represents 01:30 hours). These values count up to 96, which represents 24:00 hours. The first value must be less than the second.

The next six digits may represent one or more values used to create the setting or contain an id, which can be compared on a scanner.

For two-dimensional barcodes (QR codes), the same encoding as for one-dimensional barcodes can be used. The encoding is defined in ISO/IEC 18004:2006 and should be highly error-tolerant. An alternative option is to encode the data as an XML string. Tags and attributes are used to indicate or create settings.

The one-dimensional or two-dimensional barcode provided by the context data carrier can be scanned by a barcode reader or scanner integrated with or connected to the portable device 3. Barcode scanners use IR (infrared), lasers, or cameras to read the barcode. They convert the given code or XML into usable data or determine preset settings based on an ID. In use, this can be a handheld device with a camera. The user can open a software application running on the portable device 3, click a button to activate the camera, and hold it over the barcode. In response to reading the context data, context-related control data (settings) are generated.

In addition, another alternative embodiment is described. There are people with diabetes. These must set values for the above-mentioned use during the day. At different times of the day, the values (control data) may vary depending on different physical behaviors or activities.

In a first use case, a person with diabetes is working in an office. On their desk, they have attached a first contextual data carrier, which is provided with a first barcode indicating an insulin profile for minimal movement. After work, they go to their car, where they attach a second contextual data carrier, which is provided with a second barcode, to their steering wheel. The second barcode provides different contextual data indicating, for example, another threshold value for warning the person earlier if their individual glucose level gets low. Additionally, in the car, a third contextual data carrier, which is provided with a third barcode, can be placed that indicates another insulin profile to keep the person awake. In the evening, the person scans a fourth barcode provided on a fourth contextual data carrier for their sleep, where they are given another target range, warning limit, and insulin profile.

In the second use case, a diabetic person is going to the gym. For sports, he needs specific settings. For quick configuration, he scans the barcode of the context data carrier attached to the entrance or in his locker.

In a third use case, a person with diabetes visits a restaurant. On their plate is a contextual data carrier provided with a barcode indicating the amount of carbohydrates in the meal. The person scans the barcode. Consequently, context-related control data indicating the bolus dose of the meal is generated in the portable device 3 based on a bolus calculation for the scanned contextual data.

Claims (15)

1. A control device for providing control data in a medical system, comprising: - Portable devices (3); - A plurality of active contextual data carriers (1.1, ..., 1.n), including a first contextual data carrier placed in a first location within the usage environment of the portable device (3), wherein the plurality of active contextual data carriers (1.1, ..., 1.n) provide a local location reference system; and - The data processing system provided in the portable device (3) includes a data input interface (7) and a device controller (8) functionally connected to the data input interface (7). The data processing system is configured to: - The presence of the portable device (3) within the local location reference system is determined by determining that the portable device (3) is near one or more active context data carriers (1.1, ..., 1.n); - Receive first local contextual data from the first contextual data carrier via the data input interface (7), the first local contextual data indicating at least one of location, patient identity, patient activity, and time, wherein the first local contextual data is received by: - The receiver of the portable device (3) receives the first local context data transmitted by the transmitter of the active context data carrier; - In response to receiving the first local context data, the device controller (8) generates context-related device control data, including processing the first local context data and generating the first context-related device control data based on electronic context information derived from the processing of the first local context data; and - Output data indicating the control data of the first situation-related device is output through the data output interface (9) of the portable device (3). 2. The control device according to claim 1, wherein the first local context data is read from a passive local context data carrier, the passive local context data carrier comprising at least one of a data matrix and an electronic data storage element. 3. The control device according to claim 2, wherein the data matrix is a one-dimensional barcode or a two-dimensional barcode, and wherein the electronic data storage element is an RFID transponder. 4. The control device according to any one of claims 1 to 3, wherein the transmitter of the context data carrier and the receiver of the portable device (3) are configured to perform contactless data transmission via a transmission technology selected from the group consisting of: near-field data communication; and Bluetooth communication. 5. The control device according to any one of claims 1 to 3, wherein the portable device (3) includes a detection module functionally connected to the device controller (8), and the data processing system is further configured to detect local proximity of the portable device (3) to the first context data carrier. 6. The control device according to any one of claims 1 to 3, wherein the first context-related device control data is configured to control at least one operation of a medical device (4) selected from the group consisting of: video data output; audio data output; output of warning signals; control of pump operation; and modification of at least one of medication plan, single dose dispensing, target range of measurement results, device settings of the medical device, threshold of measurement values, insulin distribution, and time blocks defining time periods. 7. The control device according to claim 6, wherein the measurement result is a glucose value, the medical device is an insulin pump or a glucose measuring device, and the measurement value is a glucose value. 8. The control device according to any one of claims 1 to 3, wherein the portable device (3) is selected from the group consisting of: mobile phones; tablet computers; laptop computers; portable medical devices; portable medical measuring devices; and smartwatches. 9. The control device according to any one of claims 1 to 3, wherein the plurality of active context data carriers (1.1, ..., 1.n) includes a second local context data carrier placed in a second location in the usage environment of the portable device (3) that is different from the first location, the second local context data carrier providing second context data that is different from the first local context data. 10. An apparatus comprising a medical device (4) and a control device according to any one of claims 1 to 9, wherein the medical device is functionally connectable to the control device for receiving context-dependent device control data from the control device. 11. The apparatus of claim 10, wherein the medical device (4) is selected from the group consisting of: a blood glucose meter; an insulin pump; a continuous glucose monitoring system; and an insulin pen. 12. A method for controlling a medical system, comprising: - A control device is provided, the control device comprising: a portable device (3); a plurality of active contextual data carriers (1.1, ..., 1.n), having a first contextual data carrier individually placed in a first location in the usage environment of the portable device (3), wherein the plurality of active contextual data carriers (1.1, ..., 1.n) provide a local location reference system; and a data processing system provided in the portable device (3), and including a data input interface (7) and a device controller (8) functionally connected to the data input interface (7); - The presence of the portable device (3) within the local location reference system is determined by determining that the portable device (3) is near one or more active context data carriers (1.1, ..., 1.n); - Through the data input interface, first local contextual data is received from the first contextual data carrier, the first local contextual data indicating at least one of location, patient identity, patient activity, and time, wherein the first local contextual data is received by: - The receiver of the portable device (3) receives the first local context data transmitted by the transmitter of the active context data carrier; - In response to receiving the first local context data, the device controller (8) generates context-related device control data, including analyzing the first local context data and generating the first context-related device control data based on context information derived from the analysis of the first local context data; and - Output data indicating the control data of the first situation-related device is output through the data output interface (9) of the portable device (3). 13. The method of claim 12, wherein providing the control system comprises: loading a software application into the memory of the portable device (3); and running the software application on the portable device (3). 14. The method according to claim 12 or 13, further comprising: placing the first context data carrier in a user-defined location in the local usage environment of the portable device (3). 15. A computer-readable medium storing a computer program product for controlling a medical system by a control device, the control device comprising: a portable device (3); a plurality of active contextual data carriers (1.1, ..., 1.n), having a first contextual data carrier individually placed in a first location in the usage environment of the portable device (3), wherein the plurality of active contextual data carriers (1.1, ..., 1.n) provide a local location reference system; and a data processing system provided in the portable device (3) and including a data input interface (7) and a device controller (8) functionally connected to the data input interface (7), the computer program product comprising: - A component recorded on an electronic data carrier for determining the presence of the portable device (3) within the local location reference system by determining that the portable device (3) is near one or more active context data carriers (1.1, ..., 1.n); - A component recorded on an electronic data carrier for receiving first local contextual data from the first contextual data carrier via the data input interface, the first local contextual data indicating at least one of location, patient identity, patient activity, and time, wherein the first local contextual data is received by: - The receiver of the portable device (3) receives the first local context data transmitted by the transmitter of the active context data carrier; - A component recorded on an electronic data carrier for generating context-related device control data by the device controller (8) in response to receiving the first local context data, wherein generating the context-related device control data includes analyzing the first local context data and generating the first context-related device control data based on context information derived from the analysis of the first local context data; and - A component recorded on an electronic data carrier for outputting control data of the first situation-related device through the data output interface (9) of the portable device (3).