Monitoring device for drug application with a drug pen, with logging, communication and alarms

• US 10,857,303 B2
• Filed: 05/30/2016
• Issued: 12/08/2020
• Est. Priority Date: 05/29/2015
• Status: Active Grant

• Current Assignee: Insulcloud SL
• Original Assignee: Insulcloud SL
• Inventors: Arenas Latorre, Jesus, Lopez Sanchez-Pascuala, Jose Luis
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Lalonde, Alexandra
• Application Number:
  US15/578,186
• Publication Number:
  US 20180147362A1
• Time in Patent Office: 1,653 Days
• CPC Class Codes: A61M 2205/215 Tilt detection, e.g. for warning or shut-off
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

The present invention provides a device (1) for monitoring the application of a drug to a patient by means of a drug pen (100), whereby the drug pen comprises a front end provided with an injection needle and a rear end provided with an actuation pushbutton, the device comprising a body (2) which can be dismountably coupled to the pen; an injection detection means determining when a drug injection is carried out; and a processing means configured for storing the date and time of the injection when the injection detection means detects that a drug injection is carried out, whereby the body is configured to be coupled to the pushbutton of the pen such that the pushbutton is actuated by pushing directly on the body, whereby the injection detection means is implemented as actuation detector configured for detecting said pushing action.

Claims

1. A device for monitoring the application of a drug to a patient by means of a drug pen, whereby the drug pen comprises a front end provided with an injection needle and a rear end provided with an actuation pushbutton, comprising:

a body which can be dismountably coupled to the drug pen, whereby the body comprises;

an essentially frustoconical gasket having an orifice configured for housing therein the actuation pushbutton of the drug pen;

a coupling portion having a through orifice configured for housing the gasket therein such that a compression of said gasket takes place for compressing it firmly around the actuation pushbutton;

a cover portion configured for coupling to the coupling portion;

an injection detection means implemented as an actuation detector, whereby the actuation detector is a mechanical button provided in the cover portion, configured for detecting a pushing action such that the injection detection means is configured to determine when a drug injection is carried out by detecting the pushing action; and

a processing means configured for storing the date and time of the drug injection when the drug injection detection means detects that a drug injection is carried out,

wherein;

the processing means is adapted to store a dataset including the time and date of the drug injection;

the device comprises means for monitoring, at the time of application, the temperature of the drug, and the processing means is adapted to store this temperature into the dataset and whereby the device further comprises alarm means adapted to warn a user of the pen in the case that the detected drug temperature is above or below a preset threshold and if no or a wrong dose is applied or the drug injection is uncompleted and when the drug injection is completed to confirm such correct application;

the device further comprises one or more accelerometers adapted to detect the three dimensional orientation of the drug pen when the device is mounted to the drug pen, whereby the processing means is adapted to store the three dimensional orientation of the drug pen into the data set;

the device further comprises a drug kind detection means comprising a color sensor and being adapted to automatically detect the kind of applied drug when a drug injection is detected, whereby the kind of drug is identified via a color label provided at the pushbutton of the pen, and whereby the processing means is adapted to store the detection result of the drug kind detection means into the dataset; and

the pushbutton to which the body of the device is coupled, before being actuated, is retracted by turning it backwards a distance in proportion to a drug dose to be injected, as the user turns the pushbutton, an indication window shows the user a number of drug units that is being charged for injection.

2. The device according to claim 1, wherein the drug kind detection means further comprises a light emitting diode (LED), the LED being adapted to emit light such that corresponding light reflected from the color label provided at the drug pen is sensed by the color sensor to detect the kind of drug, based on the color label.

3. The device according to claim 2, wherein the drug is insulin.

4. The device according to claim 1, wherein the alarm means is for warning the patient of predetermined events.

5. The device according to claim 4, wherein the device comprises a battery charge state detector, wherein the alarm means is adapted to output an alarm based on a detection result of the battery charge state detector, when the charge state is below a predetermined threshold.

6. The device according to claim 1, wherein 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 drug pen, wherein the processing means is adapted to store the applied dosage into the dataset based on a detection result of the dosage detection means.

7. The device according to claim 1, wherein the device comprises a control clock adapted to output the date and the time of day to the processing means.

8. The device according to claim 7, wherein 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 wherein 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.

9. The device according to claim 7, wherein 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 wherein the alarm means is adapted to output an alarm if a further injection is detected within the predefined time period.

10. The device according to claim 1, further comprising a wireless communication means configured for communicating with at least one external device.

11. The device according to claim 10, wherein at least one external device is a user equipment.

12. The device according to claim 11, wherein the user equipment is a mobile phone.

13. The device according to claim 10, wherein at least one external device is an external server.

14. The device according to claim 10, wherein the wireless communication means is adapted to communicate with the user equipment via Machine to Machine communication.

15. The device according to claim 14, wherein the Machine to Machine communication is Bluetooth.

16. The device according to claim 10, wherein the wireless communication means is adapted to communicate with the at least one server via a general network.

17. The device according to claim 15, wherein the general network is the internet.

18. A method for the operation of the device according to claim 1 for monitoring the application of a drug to a patient by means of a drug pen, comprising the following steps:

detecting, by an injection detection means of the device, when a drug injection is carried out;

storing the date and time of the drug injection when the injection detection means detects that the drug injection is carried out;

storing, in a dataset, the date and time of the drug injection, an orientation of the drug pen at the time of the drug injection, the temperature of the drug at the time of the drug injection, and the detection result of the drug kind detection means;

communicating the dataset to an external device; and

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

19. The method according to claim 18, wherein the drug is insulin.

20. A system comprising the device according to claim 1, further comprising at least one external server, the device 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 when an injection is detected.

21. The system according to claim 20, wherein the processing means is adapted to detect a time period after a preset date and time, based on an output of a control clock, and wherein 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 a wireless communication means are adapted such that, the alarm is communicated to the at least one external server which in turn is adapted to automatically send a message to a user equipment.

22. The system according to claim 20, wherein the general network is the internet.

23. The device according to claim 1, wherein the dataset further includes as a further parameter an applied dose of drug at the time of application.

24. The device according to claim 1, wherein the drug is insulin.