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1. (WO2016193229) MONITORING DEVICE FOR DRUG APPLICATION WITH A DRUG PEN, WITH LOGGING, COMMUNICATION AND ALARMS
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Claims

1 . Device (1 ) for monitoring the application of a drug to a patient by means of a drug pen (100), whereby the drug pen (100) comprises a front end provided with an injection needle (103) and a rear end provided with an actuation pushbutton (101 ), characterized by comprising:

- a body (2) which can be dismountably coupled to the pen (100);

- an injection detection means (3') determining when a drug injection is carried out; and

- a processing means (4) configured for storing the date and time of the injection when the injection detection means (3, 3') detects that a drug injection is carried out, whereby the body (2) is configured to be coupled to the pushbutton (101 ) of the pen (100) such that the pushbutton (101 ) is actuated by pushing directly on the body (2), whereby the injection detection means (3, 3') is implemented as actuation detector configured for detecting said pushing action.

2. Device (1 ) according to claim 1 , whereby the processing means is adapted to store a dataset including the time and date of the injection and at least one further parameter selected from the group of kind of applied drug, preferably kind of applied insulin, temperature of drug upon application, preferably temperature of insulin upon application, applied dose of drug, preferably of insulin, and orientation of the pen at the time of application.

3. Device (1 ) according to any one of claims 1 to 2, whereby the device further comprises a drug kind detection means adapted to automatically detect the kind of applied drug when a drug injection is detected, whereby the processing means is adapted to store the detection result of the drug kind detection means into the dataset.

4. Device (1 ) according to any one of claims 1 to 3, whereby the device comprises means for detecting the temperature of the drug, preferably the insulin, at the time of injection and the processing means is adapted to store this temperature into the dataset.

5. Device (1 ) according to any one of claim 4, whereby wherein the drug kind detection means comprises a color sensor and a light emitting diode, LED, the LED being adapted to emit light such that corresponding light reflected from a color code provided at the pen is sensed by the color sensor to detect the kind of drug, preferably of insulin, based on the color code.

6. Device (1 ) according to any one of claims 1 to 5, further comprising an alarm means for warning the patient of predetermined events.

7. Device (1 ) according to claim 6, whereby the device comprises a charge state detecting

means that is adapted to detect the charge state of a drug pen, whereby the alarm means is adapted to output an alarm based on a detection result of the charge state detecting means, when the charge state is below a predetermined threshold.

8. Device (1 ) according to any one of claims 1 to 7, whereby the device further comprises a dosage detection means adapted to detect the amount of charged drug based on a setting of a dosage actuator of the pen, whereby the processing means is adapted to store the applied dosage into the dataset based on a detection result of the dosage detection means.

9. Device (1 ) according to any one of claims 1 to 8, whereby the device further comprises a pen orientation angle detection means, which is adapted to detect the orientation angle of the pen at the time of drug application, whereby the processing means is adapted to store this orientation angle of the device in the data set.

10. Device (1 ) according to claim 9, wherein the orientation angle detection means is an accelerometer adapted to detect the three dimensional orientation of the pen when the device is mounted to the pen.

1 1 . Device (1 ) according to any one of claims 1 to 10, whereby the device comprises a control clock adapted to output the date and the time of day to the processing means.

12. Device (1 ) according to any one of claims 1 to 1 1 , whereby the body (2) comprises:

- an essentially frustoconical gasket (2a) having an orifice configured for housing therein the pushbutton (101 ) of the drug pen (100);

- a coupling portion (2b) having a through orifice configured for housing the gasket (2a) therein such that a compression of said gasket (2a) takes place for compressing it firmly around the pushbutton (101 ); and

- a cover portion (2c) configured for coupling to the coupling portion (2b), whereby the injection detection means (3, 3') is provided in said cover portion (2c).

13. Device (1 ) according to any one of claims 1 to 12, whereby the actuation detector is a mechanical button (3') provided in the cover portion (2c).

14. Device (1 ) according to any one of claims 1 to 13, further comprising a wireless communication means configured for communicating with at least one external device.

15. Device (1 ) according to claim 14, whereby at least one external device is a user equipment, preferably a mobile phone.

16. Device (1 ) according to any one of claims 14 to 15, whereby at least one external device is an external server.

17. Device (1 ) according to any one of claims 14 to 16, whereby the wireless communication means is adapted to communicate with the user equipment via Machine to Machine, preferably Bluetooth, communication.

18. Device (1 ) according to any one of claims 14 to 17, whereby the wireless communication means is adapted to communicate with the at least one server via a general network, preferably via the internet.

19. Device (1 ) according to any one of claims 1 1 to 18, whereby the processing means is adapted to detect a time period after a preset date and time, based on an output of the control clock, and whereby the alarm means is adapted to output an alarm, when the processing means detects that the injection detection means has not detected an injection for a predetermined time period after a preset date and time.

20. Device (1 ) according to any one of claims 1 1 to 19, whereby the processing means is adapted to detect a predefined time period after the date and time of the injection, based on an output of the control clock, and whereby the alarm means is adapted to output an alarm if a further injection is detected within the predefined time.

21 . Method for the operation of a monitoring device (1 ) for the application of a drug to a patient by means of a drug pen (100), whereby the device (1 ) can be dismountably coupled to the drug pen (100), characterized by comprising the following steps:

- detecting, by an injection detection means (3, 3', 3") of the device (1 ), when a drug injection is carried out;

- storing the date and time of the injection when the injection detection means (3, 3') detects that a drug injection is carried out;

- storing, in a dataset, the date and time of the injection;

- communicating the dataset to an external device; and

- providing a person, through an application in the external device, information based on the dataset.

22. System comprising the device (1 ) according to any one of claims 1 to 20, further comprising at least one external server, the device (1 ) being adapted to communicate with the at least one external server such that the dataset is stored on the external server via a general network, preferably via the internet, when an injection is detected.

23. System according to claim 22, whereby the processing means is adapted to detect a time period after a preset date and time, based on an output of the control clock, and whereby the alarm means is adapted to output an alarm, when the processing means detects that the injection detection means has not detected an injection for a predetermined time period after a preset date and time, whereby the alarm means and the wireless communication means are adapted such that, the alarm is communicated to the at least one server which in turn is adapted to automatically sent a message to a user equipment.