Logging device for drug delivery device

• US 10,159,797 B2
• Filed: 06/04/2015
• Issued: 12/25/2018
• Est. Priority Date: 06/06/2014
• Status: Expired

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Andersen, Jens Christian, Krusell, Nikolaj Frogner, Nielsen, Preben Mikael
• Primary Examiner(s): Stiles, Amber
• Application Number:
  US15/315,414
• Publication Number:
  US 20170182256A1
• Time in Patent Office: 1,300 Days
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• 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 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• 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 5/31545 Setting modes for dosing
• CPC Class Codes: A61M 5/31546 Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: A61M 5/31565 Administration mechanisms, i.e. constructional features, modes of administering a dose dosing mechanisms for setting a dose A61M5/31533
• CPC Class Codes: A61M 5/3202 : Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

An add-on logging device (100, 300) mounted to a drug delivery device is turned on when the cap is removed. After a given amount of time in inactivity the sensor means of the add-on device is turned off automatically to save energy. If the user takes a dose of drug this is not detected as the add-on device is only turned on when the cap is removed. According to the present invention a warning message is provided when the cap is re-mounted after the sensor means has been turned off automatically, the warning message indicating to a user that an expelled dose may not have been detected.

Claims

1. A logging device releasably attached to a drug delivery device, the drug delivery device comprising a drug reservoir or a structure for receiving the drug reservoir, the drug reservoir comprising an outlet portion, a detachable cap adapted to cover the drug reservoir outlet portion in a mounted position, and a drug expeller comprising a dose setter allowing a user to set a dose amount of a drug to be expelled, the logging device comprising:

electronic circuitry comprising;

a sensor adapted to capture a property value related to the dose amount of the drug expelled from the drug reservoir by the drug expeller during an expelling event when the logging device has been attached to the drug delivery device,

a processor adapted to determine dose amounts based on the captured property values,

a memory adapted to store at least one dose amount,

a display adapted to display a determined dose amount and/or a time value, and a warning message, and

a switch adapted to be operated by the detachable cap, when the logging device has been attached to the drug delivery device, between an off-state when the detachable cap is in the mounted position and an on-state when the detachable cap has been detached,

wherein;

the sensor is turned on when the switch is operated from the off-state to the on-state when the detachable cap is removed,

the sensor is turned off when the switch is operated from the on-state to the off-state when the detachable cap is remounted,

the sensor is turned off automatically when a predetermined amount of time has lapsed, and

the display is turned on to display the warning message when the switch is operated from the on-state to the off-state and when the sensor has been turned off automatically, the warning message indicating to the user that the expelled dose may not have been captured.

2. The logging device as in claim 1, wherein:

the display is turned on for a predetermined amount of time to display a message when the switch is operated from the on-state to the off-state, the message being in the form of;

a last determined dose amount and/or a time value when the display is turned on without the sensor having been turned off automatically, or

the warning message when the display is turned on with the sensor being turned off automatically.

3. The logging device as in claim 1, wherein stored dose amounts determined within a given time period are combined to a single combined dose amount, and the given time period is initiated by a detected expelling event taking place:

a given amount of time after a previously detected expelling event, or

after a given detected action.

4. The logging device as in claim 3, wherein two or more dose amounts determined within the given time period are combined automatically.

5. The logging device as in claim 3, wherein the user is prompted to accept that two or more dose amounts determined within the given time period are combined.

6. The logging device as in claim 3, wherein a determined dose amount below a given value is estimated to be a priming or air shot and is not combined with another log entry.

7. The logging device as in claim 1, wherein a log comprises a time value associated with each stored dose amount.

8. The logging device as in claim 1, wherein the sensor is adapted to capture the property value in the form of an amount of rotation of a magnetic member arranged in the drug delivery device, the amount of rotation of the magnetic member corresponding to the dose amount of the drug expelled from the drug reservoir by the drug expeller.

9. The logging device as in claim 1, wherein the sensor is turned on with a time delay when the switch is operated from the off-state to the on-state.

10. A drug delivery system, comprising:

a drug reservoir or a structure for receiving the drug reservoir, the drug reservoir comprising an outlet portion;

a detachable cap adapted to cover the drug reservoir outlet portion in a mounted position;

a drug expeller comprising a dose setter allowing a user to set a dose amount of a drug to be expelled; and

electronic circuitry comprising;

a sensor adapted to capture a property value related to the dose amount of the drug expelled from the drug reservoir by the drug expeller during an expelling event,

a processor adapted to determine dose amounts based on the captured property values,

a memory adapted to store at least one dose amount,

a display adapted to display a determined dose amount and/or a time value, and a warning message, and

a switch operable by the detachable cap between an off-state when the detachable cap is in the mounted position and an on-state when the detachable cap has been detached from the drug delivery system,

wherein;

the sensor is turned on when the switch is operated from the off-state to the on-state when the detachable cap is removed,

the sensor is turned off when the switch is operated from the on-state to the off-state,

the sensor is turned off automatically when a predetermined amount of time has lapsed, and

the display is turned on to display the warning message when the switch is operated from the on-state to the off-state and when the sensor has been turned off automatically, the warning message indicating to the user that the expelled dose may not have been captured.

11. The drug delivery system as in claim 10, wherein the system is in the form of a drug delivery device comprising:

the drug reservoir,

the drug expeller, and

the electronic circuitry.

12. The drug delivery system as in claim 10, wherein the sensor is adapted to capture the property value in the form of an amount of rotation of a magnetic member arranged in the drug delivery device, the amount of rotation of the magnetic member corresponding to the dose amount of the drug expelled from the drug reservoir by the drug expeller.

13. The drug delivery system as in claim 10, wherein two or more dose amounts determined within a given time period are combined automatically.

14. The drug delivery system as in claim 10, the drug delivery device further comprising:

an identifier representing information for a specific drug type contained in the drug reservoir or a specific drug delivery device, and

a logging device for capturing information from the identifier,

wherein the electronic circuitry is adapted to create a log for a given identifier.