Dose logging device for a drug delivery device

• US 10,376,644 B2
• Filed: 04/03/2014
• Issued: 08/13/2019
• Est. Priority Date: 04/05/2013
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Krusell, Nikolaj Frogner, Jakobsen, Nikolaj Eusebius
• Primary Examiner(s): Stiles, Amber
• Application Number:
  US14/781,139
• Publication Number:
  US 20160051760A1
• Time in Patent Office: 1,958 Days
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• 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 2205/60 with identification means
• 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 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/31 Details
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31541 Means preventing setting of a dose beyond the amount remaining in the cartridge
• CPC Class Codes: A61M 5/31553 without axial movement of dose setting member
• CPC Class Codes: A61M 5/31583 based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A system comprising a sensor assembly adapted to measure a magnetic field, and a mechanical assembly comprising an indicator element with a magnet moving together therewith, the magnet being configured to generate a spatial magnetic field which relative to the sensor assembly varies corresponding to the spatial position and orientation of the magnet, wherein the indicator element is adapted to both rotate and move axially during operation of the assembly. Processor means is configured to determine on the basis of measured values both a rotational position and an axial position of the indicator element.

Claims

1. A drug delivery system comprising:

a drug delivery device,

a logging device adapted to be releasably attached to the drug delivery device,

the drug delivery device comprising;

a drug reservoir or structure for receiving a drug reservoir,

a drug expelling structure comprising a dose setting structure allowing a user to set a dose amount of drug to be expelled,

an actuation structure actuatable between a first and a second actuation state, the first actuation state allowing a dose amount to be set by the dose setting structure, the second actuation state allowing the drug expelling structure to expel a set dose,

a first indicator structure comprising a magnet moving together therewith, the magnet being configured to generate a spatial magnetic field which relative to an external sensor structure varies corresponding to a spatial position and orientation of the magnet and thus the first indicator structure, wherein the first indicator structure is adapted to rotate during operation of the drug expelling structure corresponding to an axis of rotation, an amount of rotation corresponding to an amount of drug expelled from the drug reservoir by the drug expelling structure, and

a second indicator structure operatable between a first indicator state corresponding to the first actuation state, and a second indicator state corresponding to the second actuation state, the logging device comprising;

a sensor assembly comprising one or more sensors adapted to measure a magnetic field corresponding to at least two axes,

a state sensor structure adapted to detect whether the second indicator structure is in the first or second indicator state, and

a processor structure configured to;

(i) determine on the basis of measured magnetic field values a rotational position of the first indicator structure, and

(ii) calculate an expelled dose amount based on determined rotational positions of the first indicator structure,

a storage structure adapted to store one or more dose amounts comprising at least one of (a) the dose amount of drug to be expelled, (b) the amount of drug expelled from the drug reservoir, and (c) the expelled dose amount calculated by the processor, to create a log,

wherein the first indicator structure is in the form of an indicator element comprising the magnet moving together therewith, the magnet being configured to generate a spatial magnetic field which relative to the sensor assembly varies corresponding to the spatial position and orientation of the magnet and thus the indicator element, thereby generating a spatial magnetic field which varies uniquely relative to each sensor, the indicator element being adapted to;

(i) rotate during operation of the expelling structure, and

the indicator element also forms the second indicator structure, the indicator element being adapted to;

(ii) move axially between positions corresponding to the first and the second indicator state,

wherein a calculated expelled dose amount is based on the rotational position of the first indicator structure determined when the second indicator structure has been detected to be in the first indicator state.

2. The drug delivery system as in claim 1, wherein the second indicator structure of the drug delivery device comprises a magnet, and the state sensor structure of the logging device comprises a magnetic sensor, the detection of the indicator state being based on measurements from the magnetic sensor.

3. The drug delivery system as in claim 2, wherein the sensor assembly of the logging device provides the state sensor structure.

4. The drug delivery system as defined in claim 2, wherein the sensor assembly also forms the magnetic sensor of the state sensor structure.

5. The drug delivery system as defined in claim 4, wherein the indicator element is formed fully or partly of a polymeric material containing magnetic particles, the polymeric material having been magnetized to provide the magnet producing the spatial magnetic field, and wherein the indicator element is ring-formed.

6. A logging device adapted to be releasably attached to a drug delivery device, the drug delivery device comprising:

a drug reservoir or structure for receiving a drug reservoir,

a drug expelling structure comprising a dose setting structure allowing a user to set a dose amount of drug to be expelled,

an indicator element comprising a magnet moving together therewith, the magnet being configured to generate a spatial magnetic field which relative to an external sensor structure varies corresponding to a rotational orientation of the magnet and thus the indicator element, wherein the indicator element is adapted to rotate during operation of the drug expelling structure corresponding to an axis of rotation, an amount of rotation corresponding to an amount of drug expelled from the drug reservoir by the drug expelling structure,

the logging device comprising;

a first sensor structure adapted to measure a magnetic field corresponding to at least two axes,

a second sensor structure adapted to measure a magnetic property,

a processor structure configured to determine;

(i) on the basis of measured values from the first sensor structure a rotational position of the indicator element, and

(ii) on the basis of measurements from the second sensor structure rotational movement of the indicator element,

a storage structure adapted to store one or more dose amounts comprising at least one of (a) the dose amount of drug to be expelled, and (b) an amount of drug expelled from the drug reservoir, to create a log.

7. The logging device as in claim 6, wherein the processor structure is configured to determine on the basis of measurements from the second sensor structure a number of full rotations of the indicator element.

8. The logging device as in claim 6, wherein:

the first sensor structure has a first sampling frequency, and

the second sensor structure has a second higher sampling frequency.

9. The logging device as in claim 6, comprising a sensor assembly comprising one or more sensors adapted to measure a magnetic field corresponding to a plurality of axes, wherein the first sensor structure is provided by the sensor assembly and operated to measure a magnetic field corresponding to a first number of axes, and the second sensor structure is provided by the sensor assembly and operated to measure a magnetic field corresponding to a second lower number of axes.

10. A drug delivery system comprising a logging device, in combination with a drug delivery device,

the drug delivery device comprising:

a drug reservoir or structure for receiving a drug reservoir,

a drug expelling structure comprising a dose setting structure allowing a user to set a dose amount of drug to be expelled,

an actuation structure actuatable between a first and a second actuation state, the first state allowing a dose amount to be set by the dose expelling structure, the second state allowing the drug expelling structure to expel a set dose,

a first indicator structure comprising a magnet moving together therewith, the magnet being configured to generate a spatial magnetic field which relative to an external sensor structure varies corresponding to a spatial position and orientation of the magnet and thus the first indicator structure, wherein the first indicator structure is adapted to rotate during operation of the drug expelling structure corresponding to an axis of rotation, the amount of rotation corresponding to the amount of drug expelled from the drug reservoir by the drug expelling structure, and

a second indicator structure operatable between a first indicator state corresponding to the first actuation state, and a second indicator state corresponding to the second actuation state,

the logging device comprising;

a sensor assembly comprising one or more sensors adapted to measure a magnetic field corresponding to at least two axes,

a state sensor structure adapted to detect whether the second indicator structure is in the first or second indicator state, and

a processor structure configured to;

(i) determine on the basis of measured magnetic field values a rotational position of the first indicator structure, and

(ii) calculate an expelled dose amount based on determined rotational positions of the first indicator structure,

a storage structure adapted to store one or more dose amounts to create a log, and

wherein the first indicator structure is in the form of an indicator element comprising the magnet moving together therewith, the magnet being configured to generate the spatial magnetic field which relative to the sensor assembly varies corresponding to the spatial position and orientation of the magnet and thus the indicator element, thereby generating the spatial magnetic field which varies uniquely relative to each sensor, the indicator element being adapted to;

(i) rotate during operation of the drug expelling structure, and

wherein the indicator element also forms the second indicator structure, the indicator element being adapted to;

(ii) move axially between positions corresponding to the first and the second indicator state.

11. The drug delivery system as defined in claim 10, wherein:

the indicator element is formed fully or in part of a polymeric material containing magnetic particles, the polymeric material having been magnetized to provide the magnet producing the spatial magnetic field.

12. The drug delivery system as in claim 10, wherein the indicator element is ring-formed.