Method for operating a system and a system

Abstract

The present disclosure refers to a method for operating a system, the system comprising a medical device (1), having at least one of a sensor device for sensing medical data and a medication delivery device for delivering medication, a portable electronic consumer device (2), an intermediate device (3) provided with a first communication protocol for data communication with the portable electronic consumer device (2) and a second communication protocol for data communication with the medical device (1), and a control module (6) provided in the intermediate device (3), the method comprising, in the control module (6), receiving control data from the portable electronic consumer device (2) by a receiving functionality provided in the control module (6), the control data being configured for controlling operation of the medical device (1), determining whether the control data can be confirmed by a confirmation functionality provided in the control module (6), and if the control data are confirmed, transmitting the control data to the medical device (1) by a transmission functionality provided in the control module (6). Further, a system is provided.

Claims

1. A method for operating a system comprising a portable electronic consumer device provided with a first communication protocol for data communication; a medical device, having at least one of a sensor device for sensing medical data and a medication delivery device for delivering medication, and provided with a second communication protocol for data communication; an intermediate device provided with the first communication protocol for data communication with the portable electronic consumer device and the second communication protocol for data communication with the medical device, the intermediate device including a memory device containing critical control data limits; and a control module provided in the intermediate device; the method comprising: the portable electronic consumer device transmitting critical control data to the control module; receiving in the control module the critical control data from the portable electronic consumer device by a receiving functionality provided in the control module, the critical control data being configured for controlling a critical operation function of the medical device; the control module determining that at least some of the critical control data are not within the data limits and in response the control module automatically amending such data to be amended critical control data within the data limits; in response to determining that at least some of the critical control data are not within the data limits, the control module transmitting the critical control data and the amended critical control data to the medical device, the transmitting being by a transmission functionality provided in the control module; and the control module operating the medical device according to the critical control data and the amended critical control data; wherein the critical control data and the amended critical control data are configured to control at least one of the critical operation functions of the medical device selected from the group consisting of: calibrating the sensor device, re-calibrating the sensor device, and delivering medication by the medication delivery device; and transmitting pass-through data different from the critical control data and the amended critical control data by the intermediate device in pass-through data communication, such transmitting pass-through data being free of at least the confirming.

2. The method according to claim 1, wherein the determining further comprises confirming the critical control data in response to receiving a user confirmation in the control module through an input device of the intermediate device.

3. The method according to claim 1, further comprising, in the control module, receiving safety control data from the portable electronic consumer device by the receiving functionality provided in the control module, the safety control data being configured for controlling a safety operation function of the medical device; confirming the safety control data by the confirmation functionality provided in the control module; upon confirming the safety control data, transmitting the safety control data to the medical device by the transmission functionality provided in the control module; and operating the medical device according to the safety control data; wherein the safety control data are configured to control at least one of the safety operation functions of the medical device selected from the following group: stopping current medication delivery by the medication delivery device, and manually operating medication delivery by the medication delivery device.

4. The method according to claim 1, further comprising receiving operation status data from the medical device in the intermediate device, the operation status data being indicative of an operation status of the medical device in response to operating the medical device according to the critical control data or the safety control data.

5. The method according to claim 1, further comprising performing, by the intermediate device, bi-directional data transmission with the medical device and the portable electronic consumer device.

6. A system, comprising a portable electronic consumer device provided with a first communication protocol for data communication; a medical device, having at least one of a sensor device for sensing medical data and a medication delivery device for delivering medication, and provided with a second communication protocol for data communication; an intermediate device provided with the first communication protocol for data communication with the portable electronic consumer device and the second communication protocol for data communication with the medical device, the intermediate device including a memory device containing critical control data limits; and a control module provided in the intermediate device, the control module having a receiving functionality for receiving critical control data from the portable electronic consumer device, the critical control data being configured for controlling a critical operation function of the medical device; a confirmation functionality for determining whether the critical control data can be confirmed by a confirmation function provided in the control module; and a transmission functionality for transmitting the critical control data to the medical device by a transmission function provided in the control module, if the critical control data are confirmed; the portable electronic consumer device being configured to transmit critical control data to the control module; the control module being configured to confirm whether the critical control data is within or not within the critical control data limits, the intermediate device and the control module further being configured to transmit the critical control data to the medical device only if the control module has confirmed that the critical control data is within the critical control data limits and if the control module determines that at least some of the critical control data are not within the data limits, then in response the control module is configured to automatically amend by the control module the critical control data not within the data limits to be amended critical control data within the data limits and the control module further configured to operate the medical device according to the critical control data and the amended critical control data; wherein the critical control data are configured to control at least one of the critical operation functions of the medical device selected from the group consisting of: calibrating the sensor device, re-calibrating the sensor device, and delivering medication by the medication delivery device; and the intermediate device is configured for transmitting pass-through data different from the critical control data, such transmitting of pass-through data communication being free of at least the confirming.

7. The system according to claim 6, wherein the intermediate device is a plug-in device pluggable into a plug socket of the portable electronic consumer device.

8. The system according to claim 6, wherein the intermediate device is configured to exchange electronic data with the portable electronic consumer device and the medical device by at least one of wireless data communication and wired data communication.

9. The system according to claim 6, wherein the intermediate device is provided in a wearable device.

10. The method of claim 1 in which the portable electronic consumer device is a mobile phone or a tablet computer, and the medical device is a subcutaneous sensor or an insulin pump.

Description

DESCRIPTION OF FURTHER EMBODIMENTS

(1) Following, further embodiments are described with reference to figures. In the figures, show:

(2) FIG. 1 a schematic representation of a system comprising a medical device, an intermediate device, and a portable electronic consumer device;

(3) FIG. 2 a schematic block diagram of the intermediate device; and

(4) FIG. 3 a schematic block diagram of a method for operating the system.

(5) FIG. 1 shows a schematic representation of a system comprising a medical device 1, a portable electronic consumer device 2, and an intermediate device 3 which may also be referred to as bridging device. The intermediate device 3 is provided with a first communication protocol for a data communication with the portable electronic consumer device 2 and a second communication protocol for the data communication with the medical device 1. The first and second data communication protocol may be the same. As an alternative, different communication protocols may be provided. Depending on the data communication standard necessary for data communication with the medical device 1 and the portable electronic consumer device 2, respectively, the intermediate device 3 is provided with the necessary communication protocol(s) for data communication.

(6) The portable electronic consumer device 2 may be one of a mobile phone and a tablet computer.

(7) The medical device 1 comprises at least one of a sensor device 1a for sensing medical data for a patient and a medication delivery device 1b for delivering medication. For example, medication for an infusion may be provided. The sensor device may be a subcutaneous sensor, for example, a subcutaneous sensor for continuously monitoring blood glucose level for a patient, such sensor being also referred to as subcutaneous CGM sensor. The medication delivery device may comprise an insulin pump configured to provide insulin for medication.

(8) The portable electronic consumer device 2 is capable of receiving a user input. The user input may define control data for controlling operation of the medical device 1. For example, by the control data collecting medical data by the sensor device may be started. In addition or as an alternative, the control data provided in the portable electronic consumer device 2, specifically in response to the user input, may provide for controlling the medication delivery by the medication delivery device.

(9) FIG. 2 shows a schematic representation of the intermediate device 3 comprising a data communication interface 4, a further data communication interface 5, and a control module connected to both the data communication interface 4 and the further data communication interface 5. A control module 6 connected to the data communication interfaces 4, 5 is provided with a processor for processing electronic data. Also, a memory device 7 is provided, which, as an alternative, may be part of the control module 6.

(10) The intermediate device 3 may exchange electronic data with the portable electronic consumer device 2 by wireless and/or wired data communication. The intermediate device 3 may be provided with a plug-in interface 7 to be plugged in a plug socket (not shown) of the portable electronic consumer device 2.

(11) With the control module 6 a plurality of operation functionalities is provided in the intermediate device 3, for example, by one or more software applications running in the intermediate device 3. With regard to the operation functionalities, for further explanation it is referred to FIG. 3 which is a schematic block diagram of a method for operating the system shown in FIG. 1.

(12) In a step 30, control data are provided in the portable electronic consumer device 2, for example, by receiving a user input for operation of the medical device 1. The control data are configured to control operation of the medical device 1, namely the sensor device for sensing medical data and/or the medical delivery device for delivering medication.

(13) Different control data may be in the portable electronic consumer device 2. Critical control data may be provided, the critical control data being configured for controlling a critical operation function of the medical device 1. The critical control data are configured to control at least one critical operation function of the medical device 1 selected from the group: calibrating the sensor device, re-calibrating the sensor device, and delivering medication by the medication delivery device. In addition or as an alternative, safety control data may be provided, the safety control data being configured for controlling a safety operation function of the medical device 1. The safety control data are configured to control at least one of the safety operation functions of the medical device 1 selected from the following group: stopping current medication delivery by the medication delivery device, and manually operating medication delivery by the medication delivery device.

(14) According to step 31, the control data are transmitted from the portable electronic consumer device 2 to the intermediate device 3. After receiving the control data in the intermediate device 3, by the control module 6, a confirmation process is performed in the intermediate device 3, the confirmation process being configured to confirm the control data received in the intermediate device 3. The confirmation process may be performed in step 32 for at least one of the critical control data and the safety control data, but not for other control data different from both the critical control data and the safety control data. Such other control data also provided in the intermediate device 3 may be provided through the intermediate device 3 to the medical device 1 without requiring confirmation. In general, the confirmation process may be performed for control data, but not for other control data different from the control data.

(15) The confirmation process may comprise receiving user input through a user interface 8 of the intermediate device 3. For example, the user may provide input through a touch sensitive input device. As an alternative or in addition, the confirmation process being part of a confirmation functionality provided by the control module 6 may comprise running a confirmation algorithm in the control module 6.

(16) In response to the confirmation process, the control data are confirmed, and the control data are transmitted from the intermediate device 3 to the medical device 1 (step 33). The control data, after confirmation, may be provided to the medical device 1 as received in the intermediate device 3 or as amended control data after being amended in the intermediate device 3.

(17) Following, the medical device 1 is operated according to the received control data (step 34). In step 35, operation status data may be provided in the medical device 1. The operation status data are indicating a current operation status of the medical device 1 operated according to the control data. The apparatus status data, in step 36, are sent to the intermediate device 3. According to step 37, the operation status data are transmitted from the intermediate device 3 to the portable electronic consumer device 2 where the operation status data may be outputted, thereby, informing the user of the portable electronic consumer device 2 about operation status of the medical device 1.